Saturday 24 March 2018

All posts tagged medical device

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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FDA Unveils Proposed Device Identification System, New Database

July 3, 2012 | 2 comments

The FDA has released a proposed rule that requires most medical devices distributed in the United States carry a unique […]

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FDA Issues Warning About Implantable Device

July 2, 2012 | No comments

The FDA issued a warning on Friday (June 29, 2012) regarding an implantable medical device manufactured by Covidien Plc subsidiary […]

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EU Looks to Tighten Medical Device Safety With Implant Registry

April 30, 2012 | No comments

In the wake of high-level scandals in the EU, including the Poly Implant Prothese (PIP) breast implant snafu and the metal-on-metal hip […]

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FDA Strengthens International Collaboration to Ensure Quality, Safety of Imported products

April 26, 2012 | No comments

The FDA’s Global Engagement Report shed light on the volume of imported food, medical devices, and pharmaceuticals and outlines the measures taken […]

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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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FDA reaches $1 million Settlement with Pennsylvania Medical Device Firm

February 29, 2012 | No comments

The FDA Announced today that it reached a settlement with Globus Medical Inc. for the distribution of unapproved medical devices. The FDA and Globus […]

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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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FDA Proposes Draft Guidelines to Improve the Representation of Women in Med Device Clinical Studies

December 16, 2011 | No comments

From the FDA: Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the […]

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FDA Extends Comment Period on 510(k) Guidance

November 14, 2011 | No comments

The FDA has extended the public comment period for its draft guidance on medical device 510(k) clearance for modified devices. […]

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