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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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72 records meeting your search criteria returned- Product Code: DRF Product Problem: Device Contamination with Chemical or Other Material Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
BIOSENSE WEBSTER, INC (IRWINDALE) COOLFLOW® TUBING SET 03/27/2015
BOSTON SCIENTIFIC - COSTA RICA (COYOL) INTELLAMAP ORION? 03/25/2015
BOSTON SCIENTIFIC - SAN JOSE INTELLAMAP ORION? 03/17/2015
BIOSENSE WEBSTER, INC (IRWINDALE) COOLFLOW® TUBING SET 03/09/2015
BOSTON SCIENTIFIC - COSTA RICA (COYOL) INTELLAMAP ORION? 03/03/2015
BOSTON SCIENTIFIC - SAN JOSE INTELLAMAP ORION? 02/18/2015
BIOSENSE WEBSTER, INC (IRWINDALE) COOLFLOW® IRRIGATION TUBING SET 02/05/2015
BOSTON SCIENTIFIC - SAN JOSE INTELLAMAP ORION? 02/03/2015
ARMM, INC. COOLFLOW® TUBING SET 11/19/2014
BOSTON SCIENTIFIC - COSTA RICA (COYOL) INTELLAMAP ORION? 11/11/2014
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