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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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16 records meeting your search criteria returned- Product Code: NIQ Product Problem: Unsealed Device Packaging Report Date From: 01/1/2015
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ManufacturerBrand NameDate Report Received
ABBOTT VASCULAR XIENCE SIERRA 10/03/2019
BOSTON SCIENTIFIC CORPORATION SYNERGY 06/13/2019
AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONAR 06/13/2019
AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONAR 02/22/2019
BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM C 02/26/2018
AV-TEMECULA-CT XIENCE XPEDITION EVEROLIMUS ELUTING CORO 11/30/2017
AV-TEMECULA-CT XIENCE PRIME LL EVEROLIMUS ELUTING CORON 07/26/2017
AV-TEMECULA-CT XIENCE XPEDITION EVEROLIMUS ELUTING CORO 12/22/2016
BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿ 03/03/2016
AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONAR 10/15/2015
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