DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Document issued on: May 11, 2011 You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets…
Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall
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Slim Xtreme Herbal Slimming Capsule: Undeclared Drug Ingredient
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Consumer Information on: Scandinavian Total Ankle Replacement System (STAR Ankle)
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Summary Information for: Scandinavian Total Ankle Replacement System (STAR Ankle)
Issued May 27, 2009 Approval Order Summary Labeling Other Consumer Information This document is in a Portable Document Format (PDF). Acrobat Reader is required to read this document. Updated May 10, 2011
Class I Medical Device Recall: Defibtech LLC, Lifeline and ReviveR AEDs
Recall Class: Class I Date Recall Initiated: March 14, 2011 Product: Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR. 65,885 AEDs distributed in the United States are subject to this recall. The 267 affected lots were distributed in February 2011. According to the company, all affected…
Multi-Mex Distributor Inc. Dietary Supplements: Recall
[Posted 05/10/2011] AUDIENCE: Consumer, Pediatrics ISSUE: Multi-Mex Distributor, Inc., recalled dietary supplements that may be labeled as antibiotic drugs. The recall was initiated after an FDA inspection revealed the product packaging mimics antibiotics readily available in Mexico and possibly familiar to Hispanic consumers. The products were distributed in the following states: Georgia, Tennessee, California, Illinois,…
Consumer Information on: St. Jude Medical® Trifecta? Valve
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: St. Jude Medical® Trifectaâ„¢ ValvePMA…
FDA Drug Safety Communication: Connection problems involving certain needleless pre-filled glass syringes containing adenosine and amiodarone
 Safety AnnouncementAdditional Information for Healthcare Professionals Data SummaryList of Affected Adenosine and Amiodarone ProductsIV Access Systems Known to be Incompatible with Adenosine and Amiodarone Pre-filled Glass SyringesReferences  Safety Announcement [05-06-2011] The U.S. Food and Drug Administration (FDA) is alerting the healthcare community about syringe connection problems when certain needleless glass syringes containing the…
Consumer Information on: NovoTTF-100A System
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: NovoTTF-100A SystemPMA Applicant: NovoCure Ltd.Address:…