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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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330 records meeting your search criteria returned- Product Code: NIQ Product Problem: Balloon Report Date From: 01/1/2015
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ManufacturerBrand NameDate Report Received
MEDTRONIC VASCULAR RESOLUTE ONYX RX 3.5X38MM 08/14/2020
MEDTRONIC, INC. RESOLUTE ONYX 07/28/2020
MEDTRONIC, INC. RESOLUTE ONYX¿ 05/20/2020
MEDTRONIC, INC. RESOLUTE ONYX¿ 03/31/2020
BOSTON SCIENTIFIC CORP. SYNERGY MONORAIL EVEROLIUS-ELUTING PLATI 03/05/2020
MEDTRONIC, INC. RESOLUTE ONYX¿ 01/03/2020
BOSTON SCIENTIFIC CORPORATION SYNERGY MONORAIL CORONARY STENT SYSTEM 12/31/2019
MEDINOL ELUNIR 3.0X33 US 07/08/2019
ABBOTT VASCULAR XIENCE SIERRA 05/14/2019
BOSTON SCIENTIFIC CORPORATIONS EVEROLIMUS-ELUTING PLATINUM CHROMIUM COR 03/19/2019
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