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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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27 records meeting your search criteria returned- Product Code: NIQ Product Problem: Tear, Rip or Hole in Device Packaging Report Date From: 01/1/2015
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ManufacturerBrand NameDate Report Received
ABBOTT VASCULAR XIENCE SIERRA 09/03/2020
ABBOTT VASCULAR XIENCE SIERRA 01/08/2020
ABBOTT VASCULAR XIENCE XPEDITION 10/11/2019
BOSTON SCIENTIFIC CORPORATION SYNERGY 08/19/2019
AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONAR 06/03/2019
AV-TEMECULA-CT XIENCE PROA EVEROLIMUS ELUTING CORONARY 03/26/2019
BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.5/22 03/13/2019
BOSTON SCIENTIFIC CORPORATION SYNERGY 12/18/2018
AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONAR 12/14/2018
AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONAR 12/13/2018
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