Medical Device Recall
Report: Internal FDA Reports Slams European Regulation of Medical Devices as Ineffective
April 24, 2012 | 2 comments
The FDA has criticized Europe’s review process for medical devices in an unreleased internal report, claiming the failure of some …
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Choking Hazard and Serious Injuries with the Spinbrush line of Powered Toothbrushes
March 21, 2012 | No comments
The FDA updated the Agency’s safety notice on a popular line of Spinbrush toothbrushes. The FDA said it was aware of …
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Acclarent Inspira AIR Balloon Dilation System Recalled
March 13, 2012 | No comments
The FDA issued a recall for the Acclarent Inspira AIR baloon dilation system due to the products failure to function …
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Guest Editorial: How Chinese Medical Device Manufacturers are Entering Western Markets
February 28, 2012 | 2 comments
How Chinese Medical Device Manufacturers are entering Western Markets Guest Editorial: Dr. Camilla Storaa The Chinese economy has grown to be …
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Hip Implants U.S. Rejected Sold Overseas
February 15, 2012 | No comments
One of the most frequent questions clients ask me is whether its faster or easier for a device to be …
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New Jersey Company Agrees to Halt Production of Unapproved Dental Devices
February 14, 2012 | No comments
The US Food and Drug Administration announced a consent decree with a NJ company to halt the production of an unapproved medical …
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Vitaflo USA Announces Nationwide Voluntary Recall of Renastart 14.11 oz (400g)
January 31, 2012 | No comments
The FDA released a voluntary recall notice from Vitaflo USA. Vitaflo USA is recalling Renastart 14.11 oz (400g) cans, Batch Number 12832 …
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Perfect Image Solutions, LLC Issues Voluntary Recall – A Lesson in Reviewing Regulations Before Marketing and Selling
January 20, 2012 | 2 comments
Skipping the regulatory review of a new product to determine whether its FDA regulated comes with consequences as the FDA …
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Recall:FDA warns about painkiller mix-up in Excedrin, Bufferin
January 9, 2012 | No comments
The Associated Press reported a warning from the FDA about a potential mix-up between powerful prescription pain drugs and common …
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CooperVision Announces Expanded Recall of Avaira Line of Contact Lenses
November 15, 2011 | No comments
CooperVision announced today that it is expanding its worldwide recall of the Avaira brand product line of contact lenses to …
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