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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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115 records meeting your search criteria returned- Product Code: DYB Product Problem: Device Operates Differently Than Expected Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
W.L. GORE & ASSOCIATES GORE® INTRODUCER SHEATH WITH SILICONE PI 04/18/2016
BARD ACCESS SYSTEMS GROSHONG 8F PTFE PEEL-APART PERCUTANEOUS 04/08/2016
ANGIODYNAMICS INTRODUCER, 10 FR IN ANGIODYNAMICS VORTE 04/07/2016
W.L. GORE & ASSOCIATES GORE® DRYSEAL SHEATH 04/01/2016
ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTR 03/16/2016
BOSTON SCIENTIFIC - MAPLE GROVE VESSIX 02/24/2016
BIOSENSE WEBSTER, INC. (JUAREZ) PREFACE® GUIDING SHEATH WITH MULTIPURPOS 11/24/2015
ST JUDE MEDICAL, INC. THE NANOSTIM INTRODUCER KIT 10/30/2015
ST. JUDE MEDICAL FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCE 06/05/2015
ST. JUDE MEDICAL unknown brand name 04/29/2015
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