PLEASANTON, CA–(Marketwire – November 15, 2011) – CooperVision announced today that it is expanding its worldwide recall of the Avaira brand product line of contact lenses to include a limited number of lots of Avaira Sphere contact lenses. In continued collaboration with the United States Food and Drug Administration, CooperVision is expanding the recall because [...]

The FDA has issued a Class I Recall for Mizuho Orthopedic Systems’ OSI Modular Table Systems. The incorrect removal of T-pins that support the bottom base, instead of the T-pins that support the top, may result in the lower table top and patient falling to the floor. http://www.fdanews.com/newsletter/article?issueId=15257&articleId=141718

Abbott (NYSE:ABT – News) today announced it has received U.S. Food and Drug Administration (FDA) approval for the XIENCE nano™ Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease in small vessels. XIENCE nano, which is based on the same platform as the XIENCE V® Everolimus Eluting Coronary Stent System, offers physicians [...]

Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technology, today announced the approval of the EXOSEAL™ Vascular Closure Device in the US. EXOSEAL™ incorporates a number of new advances in technology and simplicity of design to provide precise and secure extravascular arterial closure.   ”We are very pleased to announce [...]

The FDA warns a trio of companies that offer direct-to-consumer genetic tests on medical claims made in their marketing campaigns. The FDA formally warned three providers of direct-to-consumer DNA tests about medical claims the companies make that the federal watchdog agency hasn’t approved. The FDA wants the companies; American International Biotechnology Services, Lumigenix Inc and [...]

Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that its DuraSeal(TM) Exact spine sealant has been approved by the U.S. Food and Drug Administration (FDA). DuraSeal Exact spine sealant is a new, low-swell formulation of dural sealant designed as an adjunct to suturing to repair the dura during spine surgery. The [...]

(Reuters) – Johnson & Johnson, which has been plagued by repeated recalls of its consumer medicines and medical devices over the past year, on Wednesday said it recalled 107 batches of surgical sutures in December due to potential sterility problems. The recall came to light on Wednesday after the United Kingdom Medicines and Healthcare products [...]

BRIDGEWATER, N.J., Dec. 8, 2010 /PRNewswire/ –Valeritas, Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, announced today that the US Food and Drug Administration has cleared the company’s V-Go Disposable Insulin Delivery Device for the continuous subcutaneous delivery of insulin in preset basal rates and with on-demand bolus dosing [...]

ISSUE: WalkMed Infusion LLC notified healthcare professionals of a nationwide recall of the Triton Pole Mount Infusion Pump, serial numbers 001 through 500 and serial numbers TR1401 through TR 2559, manufactured and sold before June 2010. If the pump door is not closed and latched per the instructions for use located on the side of [...]

The appeal, or petition for reconsideration, is a rarely used part of the PMA process that companies can pursue when their device application is denied by one of the centers within FDA. As part of the appeals process, CDRH issued a denial letter, which EES received on October 26, 2010. The next step is for [...]