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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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316 records meeting your search criteria returned- Product Code: NIQ Product Problem: Fracture Report Date From: 01/1/2015
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ManufacturerBrand NameDate Report Received
BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO 3.0/18 02/26/2020
BIOTRONIK AG, BUELACH, SWITZERLAND ORSIRO (US) 3.0/9 02/21/2020
MEDTRONIC IRELAND RESOLUTE ONYX RX 02/20/2020
MEDTRONIC IRELAND RESOLUTE ONYX RX 02/18/2020
BOSTON SCIENTIFIC CORPORATION SYNERGY 02/11/2020
BOSTON SCIENTIFIC CORPORATION PROMUS ELITE 01/31/2020
BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER 01/30/2020
MEDTRONIC IRELAND RESOLUTE ONYX RX 01/30/2020
BOSTON SCIENTIFIC CORPORATION SYNERGY 01/27/2020
BOSTON SCIENTIFIC CORPORATION SYNERGY 01/17/2020
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