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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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7 records meeting your search criteria returned- Product Code: NIO Product Problem: Inadequacy of Device Shape and/or Size Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
W.L. GORE & ASSOCIATES GORE VIABAHN VBX BALLOON EXPANDABLE ENDO 04/13/2019
ATRIUM MEDICAL ADVANTA V12 05/09/2018
COOK IRELAND LTD ZILVER 518 VASCULAR SELF-EXPANDING STENT 08/04/2017
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTAR VASCULAR AND BILIARY STENT SYST 12/09/2015
MEDTRONIC IRELAND COMPLETE SE ILIAC 08/04/2015
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT 02/12/2015
COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT 02/05/2014
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