Monday 19 February 2018

Medical Device Recall

FDA Issues Final UniqueDevice Identification System (UDI) Rule

September 20, 2013 | No comments

Over a year since the draft rule was release the U.S. FDA on Friday issued a long-awaited rule requiring companies […]

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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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