Consumer Information on: Edwards SAPIEN 3 Transcatheter Heart 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: Edwards SAPIEN 3 Transcatheter Heart…

Class I Medical Device Recall: Medtronic Shiley Neonatal and Pediatric Tracheostomy Tubes: Switching Tubes May Cause Breathing Issues

Recall Class: Class I Date Recall Initiated: May 8, 2015 Devices: Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube Cuffless Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff Affected Product Numbers and Lot are listed below.  Manufacturing and Distribution Dates: May 2, 2013 to April 27, 2015 Number of Units Distributed in…

The FDA-CDC Antimicrobial Resistance Isolate Bank

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Mammography Facility Adverse Event and Action Report

BackgroundAs part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and that it should include information that is useful in evaluating the performance of mammography facilities nationwide. In order…

MDUFA Information Consolidated and Relocated

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