Category: Food & Drug Administration (FDA)
The FDA fines Ethicon's Advanced Sterilization Products business a total of $1.25 million over charges that the company shipped products with expiration dates that were not supported by data.
The U.S. Food & Drug Administration releases a list of pre-market approvals granted in August 2013.
Summary of PMA Originals & Supplements Approved
Summary of PMA Originals Under Review
Total Under Review: 55
Total Active: 21
Total On Hold: 34
Class I and class II recalls issued by the Center for Devices & Radiological Health in November 2013.
Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
The FDA warns again of issues that may prevent Philips' HeartStart automated defibrillators from delivering emergency therapy.
MASSDEVICE ON CALL — Medtech giant Philips Healthcare (NYSE:PHG) got renewed attention for its troubled HeartStart automated external defibrillators after the FDA this week issued a new warning letter over potentially faulty electrical components.
California ophthalmic surgery devices maker Staar Surgical will meet with the FDA early next year to discuss expanded approval for its Visian Toric ICL astigmatism-treating intra-ocular lens.
FDA regulators again put their highest-risk label on a recall of Hospira's GemStar portable infusion system, this time over concerns about its pressure sensors.
Fenwal wins FDA 510(k) clearance Alyx system software version 3.1 for plasma collection.
Fenwal Inc. said it landed 510(k) clearance from the FDA for a new version of software for its Alyx blood collection system.