MedWorm: Medical Equipment Top 20

Evaluation of Automatic Class III Designation (De Novo) Decision : K093295 added

Food and Drug Adminstration (FDA): CDRHNew — Sun, 29 Jan 2012 05:00:00 +0100

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the "De Novo" classification option as an alternate pathway to classify certain new devices that had automatically been placed in Class III due to lack of a predicate. (Source: Food and Drug Adminstration (FDA): CDRHNew)

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01.26.12 -- Acacia Subsidiary Acquires Patents For Catheter Ablation Technology

Medical Design Online Newsletters — Thu, 26 Jan 2012 14:30:00 +0100

01/26/12 Medical Design Online Newsletter (Source: Medical Design Online Newsletters)

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (New Memos Available).

Food and Drug Adminstration (FDA): CDRHNew — Mon, 23 Jan 2012 05:00:00 +0100

A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report. (Source: Food and Drug Adminstration (FDA): CDRHNew)

Teleflex Introduces Arrow NextStep Antegrade Dialysis Catheter

Medical Design Online News — Mon, 16 Jan 2012 12:00:00 +0100

Teleflex Incorporated, a leading global provider of medical devices for critical care and surgery, has expanded its interventional access portfolio with the Arrow NextStep Antegrade catheter, now available for sale in the United States (Source: Medical Design Online News)

ORLive Program Highlights Revolutionary Technology For Plastic Surgeries

Medical Design Online News — Mon, 16 Jan 2012 06:20:00 +0100

The V-LocT Absorbable Wound Closure Device is a revolutionary technology that eliminates the need to tie knots, so surgeons can close incisions faster without compromising strength and security (Source: Medical Design Online News)

Federal Register: Magnetic Resonance Imaging Safety; Public Workshop

Food and Drug Adminstration (FDA): CDRHNew — Tue, 20 Sep 2011 04:00:00 +0100

The purpose of the public workshop is to discuss factors affecting the safe use of magnetic resonance imaging (MRI) and approaches to mitigate risks. The overall goal is to discuss strategies to minimize patient and staff risk in the MRI environment. (Source: Food and Drug Adminstration (FDA): CDRHNew)

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Power Supplies meet medical and ITE safety specs.

Industrial Newsroom - Health, Medical and Dental Supplies — Wed, 22 Dec 2010 13:37:03 +0100

With 4 kVac reinforced input-to-output isolation and 1,500 Vac output-to-ground isolation, 400 W Series EFE400M meets international safety standards of IEC/UL 60601-1 for medical equipment. Digitally controlled units provide regulated outputs of 12, 24, or 48 Vdc. Featuring 3.5 x 6.5 in. footprint and less than 1U profile, devices include integrated magnetic transformer to boost efficiency to 90%. Power density is 15.6 W/in.³ under peak load conditions and 13.1 W/in.³ under continuous loading. This story is related to the following:Electrical Equipment and Systems Sponsored by: Globtek Inc. - Your Power Partner...For Over 20 Years!Health, Medical and Dental Supplies and EquipmentSearch for suppliers of: Regulated Power Supplies | Medical Power Supplies | DC Power Supplies (Source...

Single-Use, 50 in. Capsule Filter suits large-volume jobs.

Industrial Newsroom - Health, Medical and Dental Supplies — Mon, 27 Dec 2010 13:24:24 +0100

Able to be specified with choice of filter membranes, microfiber prefilters, and removal ratings from 0.04-99 µm, UltraCap® HD is optimized for continuous and batch processing in biomanufacturing operations as well as pre and final filtration in pharmaceutical applications. Filter, offered with T-style sanitary flange inlet and outlet connections, can be specified in additional nominal lengths of 10, 20, 30 and 40 in. Gammairradiated version is available for aseptic applications. This story is related to the following:Chemical Processing and Waste ManagementHealth, Medical and Dental Supplies and EquipmentSearch for suppliers of: Micron Size Filters | Pharmaceutical Filters | Continuous Filters (Source: Industrial Newsroom - Health, Medical and Dental Supplies)

Pilot project of joint scientific advice - outcome of the evaluation

MPA RSS news - — Tue, 21 Dec 2010 14:13:00 +0100

The outcome of the evaluation of the pilot project of joint scientific advice was very positive. Therefore, the collaboration between the TLV and MPA will continue. (Source: MPA RSS news -)

Evaluation of Automatic Class III Designation (De Novo) Decision : K080377 added

Food and Drug Adminstration (FDA): CDRHNew — Fri, 13 Jan 2012 05:00:00 +0100

Prevention Of Decubitus: MR Examinations Open The Way To New High-tech Materials For Bedding

Medical Devices News From Medical News Today — Sun, 18 Mar 2007 07:00:00 +0100

Decubitus, the much-feared bedsores that occur in extended rehabilitation, is a significant challenge for hospitals and rehab centres. At the European Congress of Radiology (ECR) 2007 in Vienna, radiologists from Frankfurt are now presenting special materials meant to prevent pressure ulcers from forming.Medically speaking, decubitus is a problem that originates in connective tissue. [click link for full article] (Source: Medical Devices News From Medical News Today)

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Evaluation of Automatic Class III Designation (De Novo) Decision Summaries: K102333 added

Food and Drug Adminstration (FDA): CDRHNew — Sat, 14 Jan 2012 05:00:00 +0100

Analysis and Research Based on the Adaptive Fusion Technology of the Wireless Sensor Network

Sensor Letters — Thu, 02 Feb 2012 23:51:19 +0100

(Source: Sensor Letters)

Davol, Inc., Sub. C. R. Bard, Inc. - Bard Ventralex ST Medium Circle with Strap Hernia Patch - Class 2 Recall

Medical Device Recalls — Wed, 02 Nov 2011 01:00:11 +0100

Bard¿ Ventralex" ST Medium Circle with Strap Hernia Patch Diameter 6.4cm /2.5", Catalog Number: 5950008. Intended for use in the reconstruction of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair hernias and deficiencies caused by trocars. (Source: Medical Device Recalls)

Federal Register: Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities

Food and Drug Adminstration (FDA): CDRHNew — Mon, 25 Apr 2011 04:00:00 +0100

This device is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers, such as bedsores. This reclassification is on the Secretary of... (Source: Food and Drug Adminstration (FDA): CDRHNew)

Cyberonics, Inc - VNS Therapy System Generator - Class 3 Recall

Medical Device Recalls since July 07, 2006 — Thu, 23 Apr 2009 01:00:03 +0100

Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable, multiprogrammable, vagus nerve stimulator. (Source: Medical Device Recalls since July 07, 2006)

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Avinger To Perform Two Live Ocelot Cases At LINC Conference In Leipzig, Germany

Medical Design Online News — Tue, 24 Jan 2012 08:35:58 +0100

Avinger, Inc., a medical device manufacturer of innovative, multi-functional catheters for treating patients with Peripheral Artery Disease (PAD), announces two live Ocelot cases will be transmitted by Professor Giovanni Torsello and Dr. Arne Schwindt from St. Franziskus Hospital to an expert panel and live audience at the Leipzig Interventional Course (LINC) 2012 conference in Leipzig, Germany on Friday, January 27 at 3:00 p.m. CET (Source: Medical Design Online News)

Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

Food and Drug Adminstration (FDA): CDRHNew — Fri, 13 Jan 2012 05:00:00 +0100

The FDA is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's... (Source: Food and Drug Adminstration (FDA): CDRHNew)

Public Workshop ? Magnetic Resonance Imaging Safety, October 25-26, 2011

Food and Drug Adminstration (FDA): CDRHNew — Tue, 20 Sep 2011 04:00:00 +0100

FDA is announcing a public workshop entitled: Magnetic Resonance Resonance Imaging (MRI) Safety Public Workshop. The purpose of the public workshop is to discuss factors affecting the safe use of magnetic resonance imaging MRI and approaches to mitigate (Source: Food and Drug Adminstration (FDA): CDRHNew)

Synthes USA (HQ), Inc. - Synthes Spine TPAL Spacer System. - Class 2 Recall

Medical Device Recalls — Sat, 05 Nov 2011 01:00:09 +0100

Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogeneous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. (Source: Medical Device Recalls)