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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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10 records meeting your search criteria returned- Product Code: NIQ Product Problem: Material Split, Cut or Torn Report Date From: 01/1/2015
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ManufacturerBrand NameDate Report Received
ABBOTT VASCULAR XIENCE SIERRA 11/08/2019
ABBOTT VASCULAR XIENCE SIERRA 09/18/2019
AV-TEMECULA-CT XIENCE XPEDITION EVEROLIMUS ELUTING CORO 06/03/2019
AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONAR 04/17/2019
MEDTRONIC IRELAND RESOLUTE ONYX RX 02/05/2019
BOSTON SCIENTIFIC CORPORATION SYNERGY 12/18/2018
AV-TEMECULA-CT XIENCE PROA EVEROLIMUS ELUTING CORONARY 11/27/2018
AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONAR 11/12/2018
AV-TEMECULA-CT XIENCE XPEDITION EVEROLIMUS ELUTING CORO 10/19/2018
AV-TEMECULA-CT XIENCE ALPINE EVEROLIMUS ELUTING CORONAR 10/02/2018
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