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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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68 records meeting your search criteria returned- Product Code: FGE Product Problem: Tear, Rip or Hole in Device Packaging Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
BOSTON SCIENTIFIC CORPORATION CRE PRO 06/06/2019
BOSTON SCIENTIFIC CORPORATION CRE PRO 06/05/2019
BOSTON SCIENTIFIC CORPORATION FLEXIMA 04/17/2019
BOSTON SCIENTIFIC CORPORATION CRE PRO 11/08/2018
BOSTON SCIENTIFIC CORPORATION HURRICANE RX 09/06/2018
AV-TEMECULA-CT ABSOLUTE PRO .035 SELF EXPANDING STENT S 03/22/2018
BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ BILIARY RX STENT SYSTEM 01/03/2018
BOSTON SCIENTIFIC - CORK CRE¿ WIREGUIDED 06/21/2017
BOSTON SCIENTIFIC - CORK HURRICANE¿ RX 04/05/2017
BOSTON SCIENTIFIC - COSTA RICA (COYOL) FLEXIMA¿ 03/27/2017
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