FDA Issues AED Safety Communication

December 13, 2013

An AED (automated external defibrillator) is a device that automatically analyzes the heart rhythm in victims of sudden cardiac arrest and delivers an electrical shock to restore its normal rhythm. AEDs help save lives of cardiac arrest victims when they are working properly and used correctly. Whe[...]

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Judge Orders FDA To Turn Over Documents In Spying Case

July 27, 2012

On July 23, 2012, a federal judge ordered the U.S. Food and Drug Administration to turn over previously undisclosed documents to attorneys for former and current employees of the FDA who claim that the FDA illegally spied on them after they reported allegedly improper medical device approvals by t[...]

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When Did Hip Replacement Manufacturer Know About Failures?

March 5, 2012

In an article appearing in The New York Times on February 21, 2012, it was reported that the all-metal artificial hip replacement known as the DePuy ASR (articular surface replacement) manufactured by DePuy Orthopaedics, a subsidiary of Johnson & Johnson, which was implanted in 93,000 pati[...]

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AVAIRA Toric Soft Contact Lenses Recalled

October 18, 2011

The FDA has announced a Class 1 recall for AVAIRA Toric (enfilcon A) TORIC Soft (Hydrophilic) Contact Lenses, 6 Soft Contact Lenses for Astigmatism. A Class 1 recall is the most serious type of recall and involves situations in which there is a reasonable probability that use of the recalled product[...]

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