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Medical Devices
FDA grants a humanitarian-use device designation to Cyberkinetics Neurotechnology Systems for its An...
Medical Devices
Boston Scientific acknowledges an internal study found an increased risk of late stent thrombosis wi...
Medical Devices
FDA has given 510(k) clearance to Trinity Biotech for its Uni-Gold H. pylori one-step test. Company ...
Medical Devices
C.R. Bard, Inc., Murray Hill, NJ, has received 510(k) clearance from FDA for its Memotherm Flexx bil...
Medical Devices
Baxter is recalling (Class 1) certain lots of its Duo-Vent solution sets because the devices may all...
Medical Devices
Draxis Health, Mississauga, Ontario, Canada, files a 510(k) with FDA to market Iodine-125 brachyther...
Medical Devices
FDA outlines current approaches for 510(k) submissions for ovulation prediction devices.
Medical Devices
FDA makes recommendations on study designs, quality controls, and labeling, among other topics in a ...
Medical Devices
Horizon Medical Products recalls Neostar Dialysis Catheter Kits and Central Venous Catheter Kits bec...
Medical Devices
Medtronic Heart Valves completes a recall of aortic and mitral porcine valves that did not meet spec...
Medical Devices
An FDA panel approves one Stryker ceramic hip arthroplasty innovation with conditions and rejects an...
Medical Devices
Digene Corporation seeks a fourth-quarter PMA supplement submission for a primary screen HPV test, i...
Medical Devices
FDA clears a Metrika 510(k) for its Digital Response DRx HbA1c Patient Monitor, for long-term glucos...
Medical Devices
A high FDA enforcement official says working relationships between Abbott Laboratories and FDA have ...
Medical Devices
FDA clears a Spectranetics Corporation PMA supplement for its Extreme .9 mm disposable catheter for ...
Medical Devices
FDA approves a NeuroControl IDE for its StIM System for use in restoring upper extremity function in...
Medical Devices
Closure Medical submits a 510(k) for Liquiderm, a liquid adhesive bandage for use in the treatment o...
Medical Devices
Closure Medical Corporation filed a 510(k) with FDA seeking to market its Soothe-n-Seal canker sore ...
Medical Devices
A draft policy on how CDRH will apply civil money penalties of up to $1 million under the Safe Medic...
Medical Devices
FDA has approved Biolase Technology's 510(k) for its Millennium hydrokinetic dental laser for use in...
