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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 
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140 records meeting your search criteria returned- Product Code: NIQ Product Problem: Leak / Splash Report Date From: 01/1/2015
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ManufacturerBrand NameDate Report Received
ABBOTT VASCULAR XIENCE SIERRA 01/16/2020
MEDTRONIC IRELAND RESOLUTE ONYX RX 01/10/2020
ABBOTT VASCULAR XIENCE SIERRA 11/25/2019
BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER SELECT 11/19/2019
ABBOTT VASCULAR XIENCE SIERRA 11/11/2019
MEDTRONIC IRELAND RESOLUTE ONYX RX 10/15/2019
ABBOTT VASCULAR XIENCE SIERRA 10/09/2019
ABBOTT VASCULAR XIENCE ALPINE 10/04/2019
ABBOTT VASCULAR XIENCE SIERRA 08/30/2019
ABBOTT VASCULAR XIENCE XPEDITION 08/28/2019
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