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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. (JUAREZ) LASSO¿ ELECTROPHYSIOLOGY CATHETER 04/17/2017
MEDTRONIC INC. ACHIEVE MAPPING CATHETER 03/20/2017
BIOSENSE WEBSTER, INC. (JUAREZ) WEBSTER CS CATHETER WITH EZ-STEER TECHNO 02/15/2017
BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLAMAP ORION¿ 01/05/2017
BIOSENSE WEBSTER, INC. (JUAREZ) LASSO® 2515 NAV ECO VARIABLE CATHETER 10/18/2016
BIOSENSE WEBSTER, INC. (IRWINDALE) COOLFLOW 07/22/2016
BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLAMAP ORION¿ 07/14/2016
BIOSENSE WEBSTER, INC. (JUAREZ) DECANAV¿ ELECTROPHYSIOLOGY CATHETER 03/16/2016
MEDTRONIC MEXICO ACHIEVE MAPPING CATHETER 02/25/2016
BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER 12/17/2015
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