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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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17 records meeting your search criteria returned- Product Code: LWQ Patient Problem: Regurgitation, Valvular Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
ST. JUDE MEDICAL PUERTO RICO, INC. SJM REGENT HEART VALVE W/FLEX CUFF 12/01/2020
ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL CONFORM 25/33 08/27/2020
CRYOLIFE, INC. ¿ AUSTIN ON-X PROSTHETIC MITRAL VALVE WITH STANDA 01/24/2020
ON-X LIFE TECHNOLOGIES, INC. ON-X ASCENDING AORTIC PROSTHESIS WITH TH 09/13/2019
MEDTRONIC, INC. OPEN PIVOT AP MITRAL HEART VALVE 11/27/2018
ON-X LIFE TECHNOLOGIES, INC. ON-X MITRAL PROSTHESIS 10/16/2018
MEDTRONIC HEART VALVES DIVISION AORTIC AP 07/25/2018
MEDTRONIC, INC. OPEN PIVOT AP MITRAL HEART VALVE 07/16/2018
MEDTRONIC HEART VALVES DIVISION MEDTRONIC HALL PROSTHETIC HEART VALVE 07/16/2018
ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL PROSTHETIC VALVE 06/25/2018
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