MedWorm.com provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest items from the 'Medical Device Approvals' source. Wed, 08 Feb 2012 19:15:01 +0100 http://www.medworm.com/index.php?rid=5649797&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm290153.htm The Therapy Cool Path Duo™ Ablation Catheter or the Safire BLU Duo™ Ablation Catheter is a steerable, deflectable, irrigated catheter (a long, thin, flexible tube) used to treat a certain kind of abnormal heart rhythm (arrhythmia2) called typical atrial.. (Approved: 1/25/2012) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5649797 Thu, 02 Feb 2012 05:00:00 +0100 5649797 http://www.medworm.com/index.php?rid=5639391&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm289473.htm The M-Vu Algorithm Engine is a software application designed to process digitized film images of the breast. The software analyzes the images and marks suspicious areas consistent with breast cancer for review by a radiologist. The results are displayed o (Approved: 1/23/2012) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5639391 Fri, 27 Jan 2012 05:00:00 +0100 5639391 http://www.medworm.com/index.php?rid=5630428&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm288752.htm ADVIA Centaur Anti-HBs2 (aHBs2) assay is a laboratory test used to detect antibodies associated with hepatitis B virus (HBV) infection. (Approved: 1/20/2012) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5630428 Tue, 24 Jan 2012 05:00:00 +0100 5630428 http://www.medworm.com/index.php?rid=5610838&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm288203.htm The GORE TAG Thoracic Endoprosthesis is an artificial endovascular stent graft and is used to treat isolated lesions, excluding dissections, of the descending thoracic aorta during endovascular repair. Some of the complex isolated lesions include... (Approved: 1/13/2012) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5610838 Thu, 19 Jan 2012 05:00:00 +0100 5610838 http://www.medworm.com/index.php?rid=5584431&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm284419.htm The EXCOR® Pediatric VAD is a blood pump that vibrates rhythmically and is designed to assist patients who cannot pump enough blood with their own natural heart. The device can be used in patients who cannot effectively pump blood with their left and/or.. (Approved: 12/16/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5584431 Wed, 11 Jan 2012 05:00:00 +0100 5584431 http://www.medworm.com/index.php?rid=5584432&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm286494.htm The Elecsys® Anti-HBc IgM Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis B virus (HBV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria... (Approved: 1/3/2012) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5584432 Tue, 10 Jan 2012 05:00:00 +0100 5584432 http://www.medworm.com/index.php?rid=5584433&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm286404.htm The BSD-2000 Hyperthermia System is intended to deliver focused therapeutic heating (hyperthermia); with temperatures greater than 104 Fahrenheit (40 Celsius), to cancerous tumors by applying radiofrequency (RF) energy at the frequency range of 75 to... (Approved: 11/18/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5584433 Mon, 09 Jan 2012 05:00:00 +0100 5584433 http://www.medworm.com/index.php?rid=5526855&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm284416.htm The Elecsys® Anti-HBc IgM Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis B virus (HBV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria... (Approved: 12/14/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5526855 Wed, 21 Dec 2011 05:00:00 +0100 5526855 http://www.medworm.com/index.php?rid=5526856&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm284063.htm The AtriCure Synergy Ablation System is used to destroy (ablate) heart tissue that is beating abnormally. It includes the Synergy Ablation Clamp, a handheld surgical device that destroys the heart tissue that is grasped between the clamp?s jaws during... (Approved: 12/15/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5526856 Mon, 19 Dec 2011 05:00:00 +0100 5526856 http://www.medworm.com/index.php?rid=5488356&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2F%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm283199.htm The PROMUS Element stent is a metal stent with the drug everolimus contained in a thin coating on the stent?s surface. The PROMUS Element stent is mounted on a folded balloon attached to a catheter delivery system for placement into a coronary artery... (Approved: 11/22/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5488356 Fri, 09 Dec 2011 05:00:00 +0100 5488356 http://www.medworm.com/index.php?rid=5488355&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2F%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm283201.htm The HER2 CISH pharmDx Kit is a laboratory test that uses DNA probes with chromogenic dyes attached to count how many copies of the HER2 gene, located on chromosome 17, are present in a cancer tissue sample. This test which uses a chromogenic in situ... (Approved: 11/30/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5488355 Fri, 09 Dec 2011 05:00:00 +0100 5488355 http://www.medworm.com/index.php?rid=5442899&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm278684.htm The NeuRx Diaphragm Pacing System (DPS)™ is a percutaneous, intramuscular, diaphragm motor point stimulating device intended for use in amyotrophic lateral sclerosis (ALS) patients with a stimulatable diaphragm (both right and left portions) as... (Approved: 9/28/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5442899 Wed, 23 Nov 2011 05:00:00 +0100 5442899 http://www.medworm.com/index.php?rid=5442902&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm280864.htm What is it? An optical imaging device used in the detection of malignant melanoma of atypical skin lesions. How does it work? The device uses light to image the skin through a layer of oil to generate a positive or negative result based on predefined... (Approved: 11/1/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5442902 Tue, 22 Nov 2011 05:00:00 +0100 5442902 http://www.medworm.com/index.php?rid=5442901&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm280840.htm The Edwards SAPIEN Transcatheter Heart Valve (THV) is a heart valve that is made of cow tissue attached to a stainless steel mesh frame with a polyester wrap. (Approved: 11/2/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5442901 Tue, 22 Nov 2011 05:00:00 +0100 5442901 http://www.medworm.com/index.php?rid=5442900&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm280839.htm is a transparent hyaluronic acid gel that is injected into facial tissue to smooth wrinkles and folds, especially around the nose and mouth. Hyaluronic acid is a protective, lubricating and binding gel that is produced naturally by the... (Approved: 11/14/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5442900 Tue, 22 Nov 2011 05:00:00 +0100 5442900 http://www.medworm.com/index.php?rid=5389677&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm278523.htm The XIENCE PRIME and XIENCE PRIME LL stents represent different lengths and diameters of the XIENCE PRIME stent. The XIENCE PRIME stent is a metal stent with the drug everolimus contained in a thin coating on the stent?s surface. The XIENCE PRIME stent is (Approved: 11/1/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5389677 Fri, 04 Nov 2011 04:00:00 +0100 5389677 http://www.medworm.com/index.php?rid=5389676&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm278517.htm The Elecsys® Anti-HBc IgM Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis B virus (HBV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. (Approved: 10/26/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5389676 Fri, 04 Nov 2011 04:00:00 +0100 5389676 http://www.medworm.com/index.php?rid=5389675&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm278518.htm The Assurant® Cobalt Iliac Balloon-Expandable Stent is a thin, flexible metal mesh tube that is implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries). (Approved: 10/26/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5389675 Fri, 04 Nov 2011 04:00:00 +0100 5389675 http://www.medworm.com/index.php?rid=5389674&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm278520.htm The APTIMA® HPV Assay reagents are used with the TIGRIS® DTS ® System to identify human papillomavirus (HPV) RNA from 14 high-risk genital HPV types that are commonly associated with cervical cancer. All currently approved HPV assays detect HPV genomic DN (Approved: 10/28/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5389674 Fri, 04 Nov 2011 04:00:00 +0100 5389674 http://www.medworm.com/index.php?rid=5337990&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm276637.htm Restylane is a transparent hyaluronic acid gel that is injected into a patient?s lips to increase their size. Restylane® is also approved for for injection into facial tissue to smooth wrinkles and folds, especially around the nose and mouth... (Approved: 10/11/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5337990 Thu, 20 Oct 2011 04:00:00 +0100 5337990 http://www.medworm.com/index.php?rid=5337989&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm276643.htm LeGoo is intended to be used during surgical procedures to temporarily plug a blood vessel and stop blood flow. It is comprised of a non-toxic gel that dissolves completely by water and has heat-sensitive properties. At room temperature, it is a thick... (Approved: 9/28/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5337989 Thu, 20 Oct 2011 04:00:00 +0100 5337989 http://www.medworm.com/index.php?rid=5337988&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm276640.htm EUFLEXXA® is a hyaluronate hydrogel produced from bacteria, in a phosphate-buffered saline solution. It is given as a three week treatment regimen. (Approved: 10/11/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5337988 Thu, 20 Oct 2011 04:00:00 +0100 5337988 http://www.medworm.com/index.php?rid=5337987&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm276641.htm ADVIA Centaur HBeAg Assay is a laboratory test used to detect human hepatitis Be antigen (HBeAg) in a person with a hepatitis B virus (HBV) infection. HBeAg is found in the blood only when the HBV virus is active. The presence of HBeAg in the blood... (Approved: 10/11/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5337987 Thu, 20 Oct 2011 04:00:00 +0100 5337987 http://www.medworm.com/index.php?rid=5197505&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm270832.htm Vysis ALK Break Apart FISH Probe Kit is a laboratory test that uses DNA probes with attached fluorescent dyes to detect the presence of chromosomal rearrangements of the ALK gene, located on chromosome 2, in a non-small cell lung cancer (NSCLC) tissue... (Approved: 8/26/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5197505 Tue, 06 Sep 2011 04:00:00 +0100 5197505 http://www.medworm.com/index.php?rid=5145706&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm268835.htm The Propel sinus implant is a temporary, self-absorbing implant designed to keep the spaces within and around the sinuses open following sinus surgery. The Propel sinus implant is manufactured from a synthetic material which is absorbed by the body over 4 (Approved: 8/11/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5145706 Fri, 19 Aug 2011 04:00:00 +0100 5145706 http://www.medworm.com/index.php?rid=5145705&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm268836.htm The cobas 4800 BRAF V600 Mutation Test is an automated molecular assay designed to detect the presence of a mutation in the BRAF gene in the most serious type of skin cancer (melanoma). In normal skin tissue, the B-raf protein transmits signals in... (Approved: 8/17/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5145705 Fri, 19 Aug 2011 04:00:00 +0100 5145705 http://www.medworm.com/index.php?rid=5081325&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm266190.htm This is a laboratory test used to detect antibodies produced by the immune system in patients who are chronically infected with hepatitis B virus (HBV). Antibodies are proteins produced by the body to fight against foreign substances, such as viruses... (Approved: 7/20/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5081325 Mon, 01 Aug 2011 04:00:00 +0100 5081325 http://www.medworm.com/index.php?rid=5081324&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm266191.htm This is used to re-open narrowed (stenotic) regions of the renal arteries which supply blood to the kidneys. It consists of two components, the stent and the delivery system. The stent is an implant constructed of cobalt chromium, laser-cut into a mesh... (Approved: 7/20/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=5081324 Mon, 01 Aug 2011 04:00:00 +0100 5081324 http://www.medworm.com/index.php?rid=4987439&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm261661.htm The Elecsys® Anti-HBc Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis B virus (HBV)2 infection. (Approved: 6/27/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4987439 Fri, 01 Jul 2011 04:00:00 +0100 4987439 http://www.medworm.com/index.php?rid=4987438&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm261646.htm The Elecsys® Anti-HBc Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis B virus (HBV)2 infection. (Approved: 6/22/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4987438 Fri, 01 Jul 2011 04:00:00 +0100 4987438 http://www.medworm.com/index.php?rid=4939615&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm259255.htm Solesta is a sterile gel that is injected into the anus to treat the symptoms of fecal incontinence2 (FI). (Approved: 5/27/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4939615 Wed, 15 Jun 2011 04:00:00 +0100 4939615 http://www.medworm.com/index.php?rid=4939614&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm259264.htm The Pinnacle® CoMplete® Acetabular Hip System is ceramic-on-metal artificial total hip replacement2 system, surgically implanted to completely replace a diseased or damaged hip joint. (Approved: 6/13/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4939614 Wed, 15 Jun 2011 04:00:00 +0100 4939614 http://www.medworm.com/index.php?rid=4939613&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm259302.htm The INFORM HER2 Dual ISH DNA Probe Cocktail is a laboratory test that uses DNA probes, with color-forming (chromogenic) dyes attached, to count how many copies of the HER2 gene2, located on chromosome 17, are present in a tissue sample. (Approved: 6/14/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4939613 Wed, 15 Jun 2011 04:00:00 +0100 4939613 http://www.medworm.com/index.php?rid=4896713&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm257680.htm The XIENCE nano stent is a metal stent with the drug everolimus contained in a thin coating on the stent?s surface. The XIENCE nano stent is mounted on a folded balloon attached to a catheter delivery system for placement into a coronary artery. (Approved: 5/24/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4896713 Fri, 03 Jun 2011 04:00:00 +0100 4896713 http://www.medworm.com/index.php?rid=4896712&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm257674.htm The EXOSEAL Vascular Closure Device (VCD) is composed of a bioabsorbable plug and a Plug Delivery System. The bioabsorbable plug is made entirely of a synthetic, absorbable polymer (polyglycolic acid (PGA)). (Approved: 5/19/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4896712 Fri, 03 Jun 2011 04:00:00 +0100 4896712 http://www.medworm.com/index.php?rid=4843891&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm256063.htm The Abbott RealTime HCV assay is a laboratory test that measures the amount of hepatitis C viral RNA in the blood of an individual infected with the hepatitis C virus (HCV). (Approved: 5/17/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4843891 Fri, 20 May 2011 04:00:00 +0100 4843891 http://www.medworm.com/index.php?rid=4843892&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm255283.htm VITROS® Immunodiagnostic Products HBeAg Immunoassay is a laboratory test used to detect hepatitis B e antigen associated with the hepatitis B virus (HBV)2 infection. (Approved: 5/11/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4843892 Thu, 19 May 2011 04:00:00 +0100 4843892 http://www.medworm.com/index.php?rid=4814989&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm255200.htm The RX Acculink Carotid Stent System consists of the Acculink self-expanding carotid stent mounted on the Rapid Exchange (RX) delivery system and is used to re-open narrowed (stenotic) regions of the carotid arteries in the neck which supply blood to... (Approved: 5/6/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4814989 Thu, 12 May 2011 04:00:00 +0100 4814989 http://www.medworm.com/index.php?rid=4814988&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm255199.htm The ION Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. The stent is mounted over a deflated balloon attached to the end of a long, thin... (Approved: 4/22/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4814988 Thu, 12 May 2011 04:00:00 +0100 4814988 http://www.medworm.com/index.php?rid=4814987&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm254735.htm The AcrySof® Toric posterior chamber intraocular lens (IOL) is an artificial lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. (Approved: 5/3/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4814987 Thu, 12 May 2011 04:00:00 +0100 4814987 http://www.medworm.com/index.php?rid=4807410&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm254830.htm The STAR Ankle is a non-constrained, total ankle replacement, surgically implanted to replace an ankle joint. The STAR Ankle is non-constrained because the bearing can be free to move in more than one plane along the tibial component. (Approved: 5/27/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4807410 Tue, 10 May 2011 04:00:00 +0100 4807410 http://www.medworm.com/index.php?rid=4791174&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm254501.htm The Trifecta valve is a three-leaflet stented pericardial valve designed for supra-annular placement in the aortic position. (Approved: 4/20/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4791174 Fri, 06 May 2011 04:00:00 +0100 4791174 http://www.medworm.com/index.php?rid=4791173&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.accessdata.fda.gov%2Fscripts%2Fcdrh%2Fcfdocs%2FcfTopic%2FMDA%2Fmda-list.cfm%3Flist%3D1 (Approved: 4/19/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4791173 Fri, 06 May 2011 04:00:00 +0100 4791173 http://www.medworm.com/index.php?rid=4791172&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm254480.htm The NovoTTF-100A System treats recurrent glioblastoma multiforme (GBM). (Approved: 4/8/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4791172 Fri, 06 May 2011 04:00:00 +0100 4791172 http://www.medworm.com/index.php?rid=4791171&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm254457.htm The cPAX Aneurysm Treatment System is used to treat aneurysms (localized, blood-filled ballooning areas in the wall of a blood vessel) in the brain that are particularly difficult to manage because of their size and shape... (Approved: 4/1/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4791171 Fri, 06 May 2011 04:00:00 +0100 4791171 http://www.medworm.com/index.php?rid=4791170&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm254518.htm The cobas HPV Test is an automated test run on the cobas 4800 system which is used to identify human papillomavirus (HPV) DNA from 14 high-risk genital HPV types that are commonly associated with cervical cancer. (Approved: 4/19/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4791170 Fri, 06 May 2011 04:00:00 +0100 4791170 http://www.medworm.com/index.php?rid=4749542&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm252132.htm The Carl Zeiss Meditec MEL 80™ Excimer Laser System is a refractive excimer laser designed for a particular type of surgery called LASIK2 (laser-assisted in situ keratomileusis) to change how the eye bends light (refractive surgery). The laser system... (Approved: 3/28/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4749542 Mon, 25 Apr 2011 04:00:00 +0100 4749542 http://www.medworm.com/index.php?rid=4737303&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm252131.htm The Valiant® Thoracic Stent Graft with the Captivia Delivery System is an endovascular stent graft2 and is used to repair fusiform aneurysms or saccular aneurysms/penetrating ulcers of the aorta3 in the chest. The Valiant® Thoracic Stent Graft is made... (Approved: 4/1/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4737303 Wed, 20 Apr 2011 04:00:00 +0100 4737303 http://www.medworm.com/index.php?rid=4737302&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm252130.htm The Pipeline™ Embolization Device (PED) is a braided, platinum and nickel-cobalt chromium alloy2, wire mesh cylindrical implanted device, which is placed within an artery3 in the brain to treat aneurysms4. An aneurysm is a localized, blood-filled... (Approved: 4/6/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4737302 Wed, 20 Apr 2011 04:00:00 +0100 4737302 http://www.medworm.com/index.php?rid=4764560&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm249209.htm is a hyaluronate hydrogel produced from chicken combs, in a phosphate-buffered saline solution. Gel-One® is a single treatment regimen. (Approved: 3/22/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4764560 Thu, 31 Mar 2011 04:00:00 +0100 4764560 http://www.medworm.com/index.php?rid=4659970&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm249208.htm The InterStim® Therapy System is a surgically implanted device used to help a patient reduce the number of bowel accidents (fecal incontinence)2. The InterStim® Therapy System has several components: a neurostimulator which delivers an electrical pulse... (Approved: 3/14/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4659970 Thu, 31 Mar 2011 04:00:00 +0100 4659970 http://www.medworm.com/index.php?rid=4659969&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm249209.htm is a sterile, transparent and viscoelastic gel composed of one percent hyaluronate hydrogel produced from chicken combs, in a phosphate-buffered saline solution. Gel One™ is a single treatment regimen. (Approved: 3/22/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4659969 Thu, 31 Mar 2011 04:00:00 +0100 4659969 http://www.medworm.com/index.php?rid=4646069&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm248604.htm A ring and laser catheter (handpiece), when connected to the Spectranetics XeCl (Xenon-Cloride) Excimer laser system (CVX-300), that allows a neurosurgeon to cut circular openings in an artery in the brain (i.e., perform an intracranial arteriotomy)... (Approved: 3/10/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4646069 Mon, 28 Mar 2011 04:00:00 +0100 4646069 http://www.medworm.com/index.php?rid=4623703&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm248133.htm The LAP-BAND System is a surgically implanted device that helps adults, who are at least 18 years old, eat less and lose weight. The LAP-BAND® consists of a silicone band, tubing, and an access port. The inner surface of the silicone band is inflatable... (Approved: 2/16/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4623703 Wed, 23 Mar 2011 04:00:00 +0100 4623703 http://www.medworm.com/index.php?rid=4562514&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm246400.htm The Selenia Dimensions 3D System is comprised of hardware and software upgrades to the Selenia Dimensions 2D full-field digital mammography system, which is FDA approved for conventional mammography. The hardware upgrades produces multiple, low-dose x-ray (Approved: 2/11/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4562514 Wed, 09 Mar 2011 05:00:00 +0100 4562514 http://www.medworm.com/index.php?rid=4562513&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm246401.htm The OraQuick HCV Rapid Antibody Test determines a patient?s exposure to the hepatitis C virus (HCV). Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. The presence of the antibodies... (Approved: 2/18/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4562513 Wed, 09 Mar 2011 05:00:00 +0100 4562513 http://www.medworm.com/index.php?rid=4514135&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm244469.htm The Revo MRI SureScan Pacing System is designed to deliver standard pacing therapy in patients who have slow heart rates (bradycardia). Unlike most other pacing systems, the Revo MRI SureScan Pacing System has been specifically designed and tested to... (Approved: 2/8/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4514135 Thu, 24 Feb 2011 05:00:00 +0100 4514135 http://www.medworm.com/index.php?rid=4401864&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm241148.htm The Cook Formula Balloon-Expandable Renal Stent System is used to re-open narrowed (stenotic) regions of the renal arteries which supply blood to the kidneys. It consists of two components, the stent and the delivery system. (Approved: 1/14/2011) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4401864 Wed, 26 Jan 2011 05:00:00 +0100 4401864 http://www.medworm.com/index.php?rid=4350624&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm240094.htm The Endurant Stent Graft System is used to repair aneurysms of the aorta in the abdomen. An aneurysm is a diseased, weakened and bulging section of an artery wall. The Endurant Stent Graft System is made of a fabric tube supported by a metal framework. Ea (Approved: 12/16/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4350624 Fri, 14 Jan 2011 05:00:00 +0100 4350624 http://www.medworm.com/index.php?rid=4350623&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm240092.htm The Ceramax Ceramic Hip System is a ceramic on ceramic artificial hip replacement system, surgically implanted to completely replace a hip joint. (Approved: 12/23/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4350623 Fri, 14 Jan 2011 05:00:00 +0100 4350623 http://www.medworm.com/index.php?rid=4350622&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm240091.htm The LifeStent and LifeStent XL Vascular Stent Systems are used to re-open stenotic (narrowed) regions of the superficial femoral and proximal popliteal arteries which supply blood to the legs. They consist of two components, the stent and the delivery sys (Approved: 12/23/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4350622 Fri, 14 Jan 2011 05:00:00 +0100 4350622 http://www.medworm.com/index.php?rid=4350621&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm240093.htm The Medtronic Cryocath Cryoablation system is intended todestroy (ablate) abnormal heart tissue to treat drug refractory paroxysmal atrial fibrillation (PAF), an intermittent abnormal heartbeat in the upper chambers of the heart that cannot be treated wit (Approved: 12/17/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4350621 Fri, 14 Jan 2011 05:00:00 +0100 4350621 http://www.medworm.com/index.php?rid=4193213&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm234611.htm The KODAK DirectView CR Mammography System consists of the KODAK DirectView CR Mammography Cassette with EHR-M Screen designed to fit into the Bucky device of standard mammography x-ray equipment, and the KODAK DirectView CR Mammography Feature Software.. (Approved: 11/3/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4193213 Tue, 23 Nov 2010 05:00:00 +0100 4193213 http://www.medworm.com/index.php?rid=4193212&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm234646.htm The Boston Scientific LIVIAN, COGNIS, and CONTAK RENEWAL 3 RF Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are implantable cardioverter defibrillators (ICDs) that also deliver cardiac resynchronization therapy (CRT). (Approved: 9/16/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4193212 Tue, 23 Nov 2010 05:00:00 +0100 4193212 http://www.medworm.com/index.php?rid=4180557&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm234143.htm HER2 FISH pharmDx™ is a laboratory test that uses DNA probes with fluorescent dyes attached to count how many copies of the HER2 gene, located on chromosome 17, are present in a cancer tissue sample. (Approved: 10/20/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4180557 Thu, 18 Nov 2010 05:00:00 +0100 4180557 http://www.medworm.com/index.php?rid=4176707&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm234141.htm The EC-3 Posterior Chamber IOLs (Models EC-3 and EC-3 PAL) are artificial lenses used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of... (Approved: 10/19/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4176707 Wed, 17 Nov 2010 05:00:00 +0100 4176707 http://www.medworm.com/index.php?rid=4176706&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm234142.htm HercepTest is a laboratory test that measures how much Her2 protein is being made by the cancer cells. This test has been used in patients with breast cancer and now can be used in patients with spreading (metastatic) stomach (gastric) cancer. (Approved: 10/20/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4176706 Wed, 17 Nov 2010 05:00:00 +0100 4176706 http://www.medworm.com/index.php?rid=4020028&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm227914.htm Abbott RealTime HBV is a laboratory test kit that measures the amount of hepatitis B viral DNA in the blood of an individual infected by the hepatitis B virus (HBV). Viral DNA is the genetic material from the hepatitis B virus. (Approved: 8/13/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=4020028 Fri, 01 Oct 2010 04:00:00 +0100 4020028 http://www.medworm.com/index.php?rid=3800566&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm220489.htm The OraQuick HCV Rapid Antibody Test is used to detect a patient?s exposure to the hepatitis C virus (HCV). Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. The presence of the antibodies... (Approved: 6/25/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3800566 Thu, 29 Jul 2010 04:00:00 +0100 3800566 http://www.medworm.com/index.php?rid=3765808&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm219508.htm The VisionCare Ophthalmic Technologies Implantable Miniature Telescope TM (IMT) is a system to magnify objects to improve vision in patients with end-stage, age-related macular degeneration (AMD). The IMT is surgically implanted in one eye only and is... (Approved: 7/1/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3765808 Mon, 19 Jul 2010 04:00:00 +0100 3765808 http://www.medworm.com/index.php?rid=3660807&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm215427.htm The Karl Storz Photodynamic Diagnostic D-Light C (PDD) System is used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview® (Photocure ASA, a Norwegian pharmaceutical company). (Approved: 5/28/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3660807 Mon, 14 Jun 2010 04:00:00 +0100 3660807 http://www.medworm.com/index.php?rid=3660806&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm215174.htm The Elecsys® Anti-HCV Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis C virus (HCV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. (Approved: 4/29/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3660806 Mon, 14 Jun 2010 04:00:00 +0100 3660806 http://www.medworm.com/index.php?rid=3660805&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm215169.htm The Elecsys® Anti-HCV Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis C virus (HCV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. (Approved: 4/29/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3660805 Mon, 14 Jun 2010 04:00:00 +0100 3660805 http://www.medworm.com/index.php?rid=3660804&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm215129.htm The Elecsys® Anti-HCV Immunoassay is a laboratory test used to detect antibodies associated with the hepatitis C virus (HCV) infection. Antibodies are proteins produced by the body to fight against foreign substances, such as viruses and bacteria. (Approved: 4/29/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3660804 Mon, 14 Jun 2010 04:00:00 +0100 3660804 http://www.medworm.com/index.php?rid=3654205&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm215106.htm Ethicon™ OMNEX™ is a medical sealant that is used to help stop leaks in blood vessels. It is made of two synthetic components called cyanoacrylate monomers, and does not include any human or animal materials. (Approved: 6/3/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3654205 Fri, 11 Jun 2010 04:00:00 +0100 3654205 http://www.medworm.com/index.php?rid=3583468&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm212633.htm The Esteem® is the first totally implantable hearing system used to treat moderate to severe hearing loss caused by a defective inner ear function. The Esteem® system includes three implantable components (Sound Processor, Sensor, and Driver), and externa (Approved: 3/17/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3583468 Thu, 20 May 2010 04:00:00 +0100 3583468 http://www.medworm.com/index.php?rid=3579322&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm212594.htm The Alair Bronchial Thermoplasty System is composed of a catheter with an electrode that delivers radiofrequency energy2 (a form of electromagnetic energy) directly to the airways of the lungs. A controller unit generates and controls the energy. (Approved: 4/27/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3579322 Wed, 19 May 2010 04:00:00 +0100 3579322 http://www.medworm.com/index.php?rid=3500356&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm209680.htm The Softec HD posterior chamber intraocular lens (IOL) is an artificial lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. (Approved: 4/12/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3500356 Fri, 23 Apr 2010 04:00:00 +0100 3500356 http://www.medworm.com/index.php?rid=3500355&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm209679.htm The Quick-Close Vascular Suturing System is used to stop the bleeding of a puncture site following a surgical procedure using the major artery of the thigh (femoral artery). (Approved: 4/8/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3500355 Fri, 23 Apr 2010 04:00:00 +0100 3500355 http://www.medworm.com/index.php?rid=3442075&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm207489.htm The STERIS System 1E (SS1E) is a liquid chemical sterilant processing system. The SS1E can be used to process reusable heat-sensitive devices such as endoscopes and their accessories that cannot be processed using steam. (Approved: 4/5/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3442075 Tue, 06 Apr 2010 04:00:00 +0100 3442075 http://www.medworm.com/index.php?rid=3409712&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm206197.htm The Complete SE Vascular Stent is a thin, flexible metal mesh tube that can be implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries). It consists of two parts, the stent and the delivery system. The stent is an... (Approved: 3/17/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3409712 Fri, 26 Mar 2010 04:00:00 +0100 3409712 http://www.medworm.com/index.php?rid=3401000&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm205936.htm The Express® LD Iliac Stent is an expandable, mesh-like stainless steel tube. The stent is mounted over a deflated balloon attached to the end of a long thin flexible tube called a stent delivery catheter... (Approved: 3/5/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3401000 Wed, 24 Mar 2010 04:00:00 +0100 3401000 http://www.medworm.com/index.php?rid=3296322&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm201473.htm The HeartMate II LVAS is a left ventricular assist device (LVAD) system, which is a device that helps the heart's left ventricle (the main pumping chamber of the heart) deliver blood to the rest of the body. (Approved: 1/20/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3296322 Mon, 22 Feb 2010 05:00:00 +0100 3296322 http://www.medworm.com/index.php?rid=3222009&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm199258.htm The Medtronic Melody® Transcatheter Pulmonary Valve is a manufactured replacement pulmonary heart valve that had already been previously repaired. The pulmonary valve is one of four valves in the human heart that help pump blood throughout the body. (Approved: 1/25/2010) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3222009 Fri, 29 Jan 2010 05:00:00 +0100 3222009 http://www.medworm.com/index.php?rid=3214278&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm199028.htm The ProGEL™ Pleural Air Leak Sealant is a surgical sealant made of human serum albumin and a polyethylene glycol (PEG) crosslinker that forms a clear flexible gel on mixing. Surgeons use the device to seal air leaks on lung tissue after standard closure.. (Approved: 1/14/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3214278 Wed, 27 Jan 2010 05:00:00 +0100 3214278 http://www.medworm.com/index.php?rid=3006060&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm191091.htm The CONSERVE® Plus Total Resurfacing Hip System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The CONSERVE® Plus Total Resurfacing Hip System is called a resurfacing prosthesis because... (Approved: 11/3/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=3006060 Wed, 18 Nov 2009 05:00:00 +0100 3006060 http://www.medworm.com/index.php?rid=2965320&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm189301.htm The VIDAS fPSA rt Assay is a lab tests, used along with digital rectal examination, to help diagnose prostate cancer in men age 50 years and older. (Approved: 10/8/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2965320 Thu, 05 Nov 2009 05:00:00 +0100 2965320 http://www.medworm.com/index.php?rid=2867403&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm185478.htm The DuraSeal Spine Sealant System is used in spinal surgery and applied over sutures (stitches) to prevent cerebrospinal fluid (CSF) from leaking out of the incision site. (Approved: 9/4/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2867403 Tue, 06 Oct 2009 04:00:00 +0100 2867403 http://www.medworm.com/index.php?rid=2676540&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm176124.htm is an implant of poly-L-lactic acid (PLLA) microparticles. It is injected into the facial tissue to correct shallow to deep smile lines (nasolabial fold) contour deficiencies and other facial wrinkles. (Approved: 7/28/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2676540 Thu, 06 Aug 2009 04:00:00 +0100 2676540 http://www.medworm.com/index.php?rid=2669326&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm175797.htm The TAXUS® Liberte™ Long (2.75?4.00 mm x 38 mm) Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. (Approved: 7/13/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2669326 Tue, 04 Aug 2009 04:00:00 +0100 2669326 http://www.medworm.com/index.php?rid=2554379&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm169592.htm The TAXUS® Liberté® Atom™ (2.25 mm) Paclitaxel-Eluting Coronary Stent is an expandable, mesh-like stainless steel tube with a drug (paclitaxel) contained within a thin polymer coating on its surface. (Approved: 5/21/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2554379 Mon, 29 Jun 2009 04:00:00 +0100 2554379 http://www.medworm.com/index.php?rid=2444382&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm162968.htm The BRYAN® Cervical Disc is a titanium and polyurethane device that fits between adjacent neck bones (vertebral bodies) to replace a diseased or bulging cervical disc that is causing neck or arm pain. (Approved: 5/12/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2444382 Wed, 27 May 2009 04:00:00 +0100 2444382 http://www.medworm.com/index.php?rid=2491748&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2FMedicalDevices%2FProductsandMedicalProcedures%2FDeviceApprovalsandClearances%2FRecently-ApprovedDevices%2Fucm149812.htm REPEL-CV Bioresorbable Adhesion Barrier is a single use, synthetic, bioresorbable polymeric film composed of poly-lactic acid (PLA) and polyethylene glycol (PEG). (Approved: 3/6/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2491748 Thu, 07 May 2009 04:00:00 +0100 2491748 http://www.medworm.com/index.php?rid=2334852&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080006.html The Medtronic® Attain Ability™ Model 4196 Lead (Model 4196) is a surgically implanted insulated wire that is designed to be used as part of a biventricular pacemaker system. (Approved: 4/7/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2334852 Fri, 17 Apr 2009 04:00:00 +0100 2334852 http://www.medworm.com/index.php?rid=2334851&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080023.html The ARCHITECT ® CORE Reagent Kit , Calibrator, and Controls constitute a laboratory test used to detect antibodies (anti HBc) associated with the hepatitis B virus (HBV) core antigen. (Approved: 4/10/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2334851 Fri, 17 Apr 2009 04:00:00 +0100 2334851 http://www.medworm.com/index.php?rid=2334856&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP940015S012.html Synvisc-One™ (hylan G-F 20) is an elastoviscous high molecular weight fluid containing hylan polymers (derivatives of hyaluronan or sodium hyaluronate) produced from chicken combs. Synvisc-One is a single 6 mL injection treatment regimen. The total... (Approved: 2/26/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2334856 Mon, 13 Apr 2009 04:00:00 +0100 2334856 http://www.medworm.com/index.php?rid=2334855&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080002.html The FC2 female condom is a sheath with one open end. There is an outer ring at the open end, and, although not attached to the condom, there is an inner ring inside the sheath that aids in insertion. (Approved: 3/10/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2334855 Mon, 13 Apr 2009 04:00:00 +0100 2334855 http://www.medworm.com/index.php?rid=2334854&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080014.html These reagents are used with the Invader Call Reporter TM softwareto identify human papillomavirus (HPV) DNA from 14 high-risk genital HPV types that are commonly associated with cervical cancer. If test results are positive, the patient is likely to... (Approved: 3/12/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2334854 Mon, 13 Apr 2009 04:00:00 +0100 2334854 http://www.medworm.com/index.php?rid=2334853&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080015.html These reagents are used with the Invader Call ReporterTM software to identify DNA from human papillomavirus (HPV) types 16 and 18 in cervical samples. If test results are positive, the patient is likely to be infected with HPV type 16, 18 or both 16... (Approved: 3/12/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2334853 Mon, 13 Apr 2009 04:00:00 +0100 2334853 http://www.medworm.com/index.php?rid=2252195&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080021.html The AVS, Inc. XACT ® Foldable Hydrophobic Acrylic UV Light-Absorbing Posterior Chamber IOL is plastic lens used to replace the natural lens after it is removed during cataract surgery to restore vision. (Approved: 2/2/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2252195 Mon, 09 Mar 2009 04:00:00 +0100 2252195 http://www.medworm.com/index.php?rid=2252193&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP030031S011.html The NAVISTAR® THERMOCOOL® Irrigated Deflectable Diagnostic/Ablation Catheter is used to destroy (ablate) abnormal heart tissue that causes an intermittent abnormal heartbeat in the upper chambers of the heart (paroxysmal atrial fibrillation). (Approved: 2/6/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2252193 Mon, 09 Mar 2009 04:00:00 +0100 2252193 http://www.medworm.com/index.php?rid=2252192&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070014.html The LifeStent FlexStar and FlexStar XL Vascular Stent Systems are used to re-open stenotic (narrowed) regions of the superficial femoral and proximal popliteal arteries which supply blood to the legs. (Approved: 2/13/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2252192 Mon, 09 Mar 2009 04:00:00 +0100 2252192 http://www.medworm.com/index.php?rid=2231112&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FH050003.html What is it? A totally implanted brain stimulator intended to suppress symptoms associated with Obsessive Compulsive Disorder (OCD) that are not adequately controlled with medications and/or other therapies. (Approved: 2/19/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2231112 Tue, 03 Mar 2009 05:00:00 +0100 2231112 http://www.medworm.com/index.php?rid=2146837&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080010.html The TECNIS® Multifocal Foldable Intraocular Lens is a plastic lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. (Approved: 1/16/2009) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2146837 Fri, 30 Jan 2009 05:00:00 +0100 2146837 http://www.medworm.com/index.php?rid=2140618&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060006.html The Express® SD Renal Monorail® Premounted Stent System is used to re-open stenotic (narrowed) regions of the renal arteries which supply blood to the kidneys, and it consists of two components, the stent and the delivery system. (Approved: 12/11/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2140618 Wed, 28 Jan 2009 05:00:00 +0100 2140618 http://www.medworm.com/index.php?rid=2140617&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080011.html BIOFINITY® is an extended wear soft contact lens that may be worn continuously for up to 6 nights and 7 days. The lens material is approximately 48% water and 52% comfilcon A (a silicone-containing hydrogel). (Approved: 11/19/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2140617 Wed, 28 Jan 2009 05:00:00 +0100 2140617 http://www.medworm.com/index.php?rid=2032043&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080007.html The E-LUMINEXX Vascular Stent is a thin, flexible metal mesh tube that can be implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries). (Approved: 12/4/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=2032043 Thu, 11 Dec 2008 05:00:00 +0100 2032043 http://www.medworm.com/index.php?rid=1989131&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060030.html This laboratory test measures the amount of hepatitis C viral RNA in a patient?s blood. Viral RNA (ribonucleic acid) is genetic material from the hepatitis C virus. (Approved: 10/30/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1989131 Wed, 26 Nov 2008 05:00:00 +0100 1989131 http://www.medworm.com/index.php?rid=1979237&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050029.html The Helios II Ablation Catheter is a magnetically guided catheter that is used to treat certain kinds of abnormal heart rhythms (arrhythmia) by finding the source of the rhythm disturbances and destroying (ablating) small areas of heart tissue. The... (Approved: 10/8/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1979237 Fri, 21 Nov 2008 05:00:00 +0100 1979237 http://www.medworm.com/index.php?rid=1979236&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050019.html The Carotid WALLSTENT ® Monorail ® Endoprosthesis is an implant used to re-open narrowed (stenotic) regions of the carotid arteries in the neck which supply blood to the brain. This device consists of the stent and a stent delivery system... (Approved: 10/23/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1979236 Fri, 21 Nov 2008 05:00:00 +0100 1979236 http://www.medworm.com/index.php?rid=1847380&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP080004.html The Hoya iSpheric™ Model YA-60BB IOL is a plastic lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of the eye's lens, resulting... (Approved: 9/26/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1847380 Thu, 02 Oct 2008 04:00:00 +0100 1847380 http://www.medworm.com/index.php?rid=1847379&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050028.html The COBAS Taqman HBV Test For Use With The High Pure System is a laboratory test kit that measures the amount of hepatitis B viral DNA in the blood of an individual infected by the hepatitis B virus (HBV). Viral DNA (deoxyribonucleic acid) is the... (Approved: 9/4/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1847379 Thu, 02 Oct 2008 04:00:00 +0100 1847379 http://www.medworm.com/index.php?rid=1847378&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060022.html Akreos ® posterior chamber intraocular lens (IOL) is an artificial lens used to restore vision and replace the natural lens of the eye after it is removed during cataract surgery. A cataract is a gradual thickening, hardening and clouding of the eye's... (Approved: 9/5/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1847378 Thu, 02 Oct 2008 04:00:00 +0100 1847378 http://www.medworm.com/index.php?rid=1719780&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070006.html T-Spot.TB is a laboratory test kit which contains reagents to detect the immune response of Thymus cells (T cells) found in an individual?s white blood cells that are stimulated by proteins produced by the bacteria that causes tuberculosis (TB). (Approved: 7/25/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1719780 Wed, 20 Aug 2008 04:00:00 +0100 1719780 http://www.medworm.com/index.php?rid=1673936&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050040.html The SPOT-Light ® HER2 CISH ™ kit is a laboratory test that uses DNA probes to measure the number of copies of Her-2 gene on chromosome 17 in breast cancer cells by a chromogenic method. (Approved: 7/1/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1673936 Fri, 01 Aug 2008 04:00:00 +0100 1673936 http://www.medworm.com/index.php?rid=1654778&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070013.html Evolence® Collagen Filler is a sterile, injectable, biodegradable, yellowish, opaque gel that is injected into the inner layers of facial skin (mid to deep dermis) in order to correct moderate to deep facial wrinkles and folds such as those around the... (Approved: 6/27/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1654778 Fri, 25 Jul 2008 04:00:00 +0100 1654778 http://www.medworm.com/index.php?rid=1614826&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060039.html The Medtronic ® Attain StarFix™ Model 4195 Lead is a surgically implanted insulated wire that is designed to be used as a part of a biventricular pacemaker system. The 4195 lead is designed to be implanted in a branch of the coronary vein that goes over.. (Approved: 6/13/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1614826 Fri, 11 Jul 2008 04:00:00 +0100 1614826 http://www.medworm.com/index.php?rid=1574812&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070016.html The Zenith® TX2 ® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System is used to repair aneurysms of the aorta in the chest. An aneurysm is a diseased, weakened and bulging section of an artery wall. (Approved: 5/21/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1574812 Thu, 03 Jul 2008 04:00:00 +0100 1574812 http://www.medworm.com/index.php?rid=1574811&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070015.html The XIENCE V Stent is a metal scaffold with the drug everolimus contained in a thin coating. The XIENCE V Stent is mounted on a folded balloon attached to a catheter delivery system, for placement into the coronary artery (blood vessel supplying blood... (Approved: 7/2/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1574811 Thu, 03 Jul 2008 04:00:00 +0100 1574811 http://www.medworm.com/index.php?rid=1515815&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070008.html The Stratos LV (-T) Cardiac Resynchronization Therapy Pacemakers (CRT-P) are rate adaptive pulse generators that also provide Cardiac Resynchronization Therapy (CRT) for patients with heart failure. (Approved: 5/12/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1515815 Fri, 13 Jun 2008 04:00:00 +0100 1515815 http://www.medworm.com/index.php?rid=1506775&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070007.html The Talent™ Thoracic Stent Graft System is used to repair aneurysms of the aorta in the chest. An aneurysm is a diseased, weakened and bulging section of an artery wall. The Talent™ Thoracic Stent Graft System is made of a fabric tube... (Approved: 6/5/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1506775 Tue, 10 Jun 2008 04:00:00 +0100 1506775 http://www.medworm.com/index.php?rid=1506774&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060027.html The Ovatio CRT-D System is used to help treat congestive heart failure, a condition where the heart can not adequately pump blood around the body. It does this by providing specially timed electrical impulses to simultaneously stimulate... (Approved: 5/15/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1506774 Tue, 10 Jun 2008 04:00:00 +0100 1506774 http://www.medworm.com/index.php?rid=1422224&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp060040.html The HeartMate II LVAS is a left ventricular assist device (LVAD) system; a device that helps the heart?s left ventricle (the main pumping chamber of the heart) deliver blood to the rest of the body. The HeartMate II LVAS includes... (Approved: 4/21/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1422224 Tue, 06 May 2008 04:00:00 +0100 1422224 http://www.medworm.com/index.php?rid=1379150&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070027.html The Talent™ Abdominal Stent Graft System is used to repair aneurysms of the aorta in the abdomen (belly). An aneurysm is a diseased, weakened and bulging section of an artery wall. The Talent™ Abdominal Stent Graft System is made of a fabric... (Approved: 4/15/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1379150 Thu, 17 Apr 2008 04:00:00 +0100 1379150 http://www.medworm.com/index.php?rid=1366156&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP010012S037.html The CONTAK RENEWAL® 3 AVT CRT-D® is an implantable cardioverter defibrillator (ICD) that also delivers cardiac resynchronization therapy (CRT) and atrial therapies. (Approved: 3/13/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1366156 Fri, 11 Apr 2008 04:00:00 +0100 1366156 http://www.medworm.com/index.php?rid=1334060&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050020.html The FreeStyle Navigator Glucose Monitoring System is a glucose sensor that reports glucose values continuously for up to 120 hours. These readings are used with fingerstick results to detect trends and patterns in glucose levels in adults, age 18 and... (Approved: 3/12/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1334060 Fri, 28 Mar 2008 04:00:00 +0100 1334060 http://www.medworm.com/index.php?rid=1224617&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060033.html The Endeavor® Zotarolimus-Eluting Coronary Stent is a tiny, expandable, mesh-like tube made of a cobalt-based metal with a drug (called zotarolimus) contained within a thin polymer coating on its surface. The Stent is mounted over a deflated... (Approved: 2/1/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1224617 Tue, 12 Feb 2008 05:00:00 +0100 1224617 http://www.medworm.com/index.php?rid=1222114&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FK063765.html The xTAG™ Respiratory Viral Panel (RVP) assay is a new device that can simultaneously detect and identify nucleic acids of multiple respiratory viruses in nasopharyngeal swab specimens from individuals suspected of respiratory tract infections. Acute... (Approved: 1/3/2008) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1222114 Mon, 11 Feb 2008 05:00:00 +0100 1222114 http://www.medworm.com/index.php?rid=1111051&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp070001.html The ProDisc™-C Total Disc Replacement is a device made from metal and plastic that is placed between two adjacent vertebral bodies (neck bones) to replace a diseased cervical disc. The ProDisc™-C Total Disc Replacement consists of three parts... (Approved: 12/17/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1111051 Fri, 21 Dec 2007 05:00:00 +0100 1111051 http://www.medworm.com/index.php?rid=1089918&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp060037.html The NexGen ® LPS-Flex Mobile Bearing Knee and LPS-Mobile Bearing Knee are artificial mobile bearing knee systems that are designed to replace the knee joint. (Approved: 12/10/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1089918 Wed, 12 Dec 2007 05:00:00 +0100 1089918 http://www.medworm.com/index.php?rid=1089917&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp060035.html The ARCHITECT ® CORE-M is a lab test used to detect antibodies associated with hepatitis B (HBV) infection. ARCHITECT® CORE-M Reagent Kit, Calibrators, and Controls are used to detect antibodies associated with HBV infection. (Approved: 11/6/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1089917 Wed, 12 Dec 2007 05:00:00 +0100 1089917 http://www.medworm.com/index.php?rid=1032230&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp060038.html The Mitroflow Aortic Pericardial Heart Valve is intended for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. The Mitroflow valve consists of a single piece of bovine pericardium that is preserved with... (Approved: 10/23/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1032230 Fri, 16 Nov 2007 05:00:00 +0100 1032230 http://www.medworm.com/index.php?rid=1032229&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070012.html The Exponent® Self-Expanding Carotid Stent with Over-the-Wire (OTW) Delivery System and the Exponent® Self-Expanding Carotid Stent with Rapid-Exchange (RX) Delivery System are used to re-open stenotic (narrowed) regions of the carotid arteries... (Approved: 10/23/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=1032229 Fri, 16 Nov 2007 05:00:00 +0100 1032229 http://www.medworm.com/index.php?rid=981680&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FH990002.html Epicel® cultured epidermal autografts (CEAs), or skin grafts, are sheets of autologous keratinocytes (skin cells) used to replace the epidermal, or top layer of skin on severely burned patients. The patient?s own skin cells are grown or cultured from a... (Approved: 10/25/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=981680 Fri, 26 Oct 2007 04:00:00 +0100 981680 http://www.medworm.com/index.php?rid=976038&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP070009.html The REALIZE™ Band is a surgically implanted device used to help a person lose weight. The REALIZE™ Band consists of a silicone band, tubing, and an injection port. (Approved: 9/28/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=976038 Wed, 24 Oct 2007 04:00:00 +0100 976038 http://www.medworm.com/index.php?rid=895272&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP040040.html The AMPLATZER ® Muscular VSD Occluder is a device placed via a catheter into the muscular ventricular septum, which separates the two ventricles of the heart, in order to close a hole, known as a ventricular septal defect (VSD). The device consists of... (Approved: 9/7/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=895272 Mon, 24 Sep 2007 04:00:00 +0100 895272 http://www.medworm.com/index.php?rid=885037&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp050043.html The Femoral Introducer Sheath and Hemostasis Device (FISH™) is used to stop bleeding at a puncture site following 5, 6, or 8 French diagnostic, cardiac catheterization procedures. Instead of using manual compression (using the hands) or mechanical... (Approved: 8/20/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=885037 Wed, 19 Sep 2007 04:00:00 +0100 885037 http://www.medworm.com/index.php?rid=813622&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060002.html The FLAIR Endovascular Stent Graft is used to treat a stenosis, a narrowing or blockage, which has developed at the connection of a vein and an arteriovenous (A-V) access graft, known as the venous anastomosis. An A-V access graft acts as an artificial... (Approved: 7/23/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=813622 Tue, 21 Aug 2007 04:00:00 +0100 813622 http://www.medworm.com/index.php?rid=810695&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050024.html An ?ablation catheter? is a plastic tube used to destroy (ablate) abnormal tissue or tissue that allows a rapid heart beat to occur. The CryoCor Cryoablation System causes ablation by applying extreme cold at the tip of the catheter, destroying the... (Approved: 8/1/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=810695 Mon, 20 Aug 2007 04:00:00 +0100 810695 http://www.medworm.com/index.php?rid=794843&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP930016s025.html These devices include a refractive excimer laser system that uses invisible ultraviolet (UV) light pulses to remove precise amounts of corneal tissue from the eye according to the treatment plan; an eyetracker that detects the position of the eye and... (Approved: 7/11/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=794843 Mon, 13 Aug 2007 04:00:00 +0100 794843 http://www.medworm.com/index.php?rid=782530&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FK061542.html The Binax Now® Malaria Test is a rapid laboratory antigen test that can detect plasmodium parasites using a whole blood sample drawn from a vein or obtained by a finger stick. This is the first FDA product cleared for detection and identification of... (Approved: 6/13/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=782530 Mon, 06 Aug 2007 04:00:00 +0100 782530 http://www.medworm.com/index.php?rid=777012&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060017.html The GeneSearch BLN Test Kit is a qualitative in vitro diagnostic test for the rapid detection of metastases larger than 0.2 mm in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. (See explanation of sentinel lymph node... (Approved: 7/16/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=777012 Fri, 03 Aug 2007 04:00:00 +0100 777012 http://www.medworm.com/index.php?rid=762662&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050016.html The Cormet Hip Resurfacing System is a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The Cormet System is called a resurfacing prosthesis because only the surface of the femoral head (ball)... (Approved: 7/3/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=762662 Fri, 27 Jul 2007 04:00:00 +0100 762662 http://www.medworm.com/index.php?rid=741105&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060018.html The PRESTIGE® Cervical Disc System is a two-piece metal device that is attached to adjacent vertebral bodies (neck bones) with bone screws to replace a diseased cervical disc. (Approved: 7/16/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=741105 Wed, 18 Jul 2007 04:00:00 +0100 741105 http://www.medworm.com/index.php?rid=721106&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fp050039.html The NOVATION™ Ceramic Articulation Hip System is an alumina ceramic artificial hip replacement system, surgically implanted to completely replace a diseased or damaged hip joint. (Approved: 7/5/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=721106 Mon, 09 Jul 2007 04:00:00 +0100 721106 http://www.medworm.com/index.php?rid=721105&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2Fk051338.html The INRange Remote Medication Management System is composed of clinical and communications software, a medication delivery unit, and medication packaging. The system is intended for use under the supervision of a licensed healthcare practitioner to... (Approved: 6/13/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=721105 Mon, 09 Jul 2007 04:00:00 +0100 721105 http://www.medworm.com/index.php?rid=694030&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP050012S001.html The STS-7 Continuous Glucose Monitoring System is a glucose sensor for home use that reports glucose values every 5 minutes for up to 7 days before a new sensor must be inserted. These readings are used with fingerstick glucose measurements to detect... (Approved: 5/31/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=694030 Mon, 25 Jun 2007 04:00:00 +0100 694030 http://www.medworm.com/index.php?rid=669015&cid=s_30476_23_f&fid=30476&url=http%3A%2F%2Fwww.fda.gov%2Fcdrh%2Fmda%2Fdocs%2FP060034.html The MONOLISA™ Anti-HBc IgM EIA is a lab test used to detect antibodies associated with hepatitis B (HBV) infection. Antibodies are substances produced by the body to fight against foreign substances called antigens, such as HBV core antigen. Presence... (Approved: 5/31/2007) (Source: Medical Device Approvals) Medical Device Approvals news http://www.medworm.com/rss/comments.php?id=669015 Fri, 15 Jun 2007 04:00:00 +0100 669015