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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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274 records meeting your search criteria returned- Product Code: OAD Report Date From: 1/1/2015 Report Date To: 12/31/2015
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ManufacturerBrand NameDate Report Received
BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOL 09/30/2015
ST. JUDE MEDICAL, INC. THERAPY¿ COOL FLEX¿ ABLATION CATHETER, U 09/30/2015
ST. JUDE MEDICAL, INC THERAPY¿ COOL FLEX¿ ABLATION CATHETER, U 09/30/2015
ST. JUDE MEDICAL, INC. THERAPY¿ COOL PATH¿ DUO ABLATION CATHETE 09/24/2015
BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR® THERMOCOOL® 09/24/2015
BIOSENSE WEBSTER, INC (IRWINDALE) EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL 09/23/2015
BIOSENSE WEBSTER, INC. (JUAREZ) GENERIC-EZ STEER TCOOL NONNAV THR 09/23/2015
BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOL 09/23/2015
BOSTON SCIENTIFIC - COSTA RICA (COYOL) INTELLATIP MIFI¿ XP TEMPERATURE ABLATION 09/22/2015
BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLATIP MIFI¿ XP TEMPERATURE ABLATION 09/21/2015
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