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U.S. Department of Health and Human Services

Manufacturer and User Facility Device Experience (MAUDE)

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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500 records meeting your search criteria returned. The results are incomplete - please narrow your search.

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ManufacturerBrand NameDate Report Received
ST. JUDE MEDICAL, COSTA RICA LTDA (CVD) SJM TRIFECTA VALVE 07/10/2020
EDWARDS LIFESCIENCES EDWARDS INTUITY ELITE AORTIC VALVE 07/09/2020
MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS 07/09/2020
MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS 07/09/2020
EDWARDS LIFESCIENCES INSPIRIS RESILIA AORTIC VALVE 07/08/2020
ST. JUDE MEDICAL, COSTA RICA LTDA SJM TRIFECTA VALVE 07/06/2020
EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE 06/30/2020
ST. JUDE MEDICAL BRASIL LTDA. (NOVA LIMA EPIC SUPRA VALVE W/FLEXFIT 06/30/2020
EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE 06/26/2020
MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS 06/25/2020
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