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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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11 records meeting your search criteria returned- Product Code: LWQ Product Problem: Structural Problem Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
SORIN GROUP USA/LIVA NOVA USA, INC TISSUE VALVE AORTIC 23MM 07/12/2019
SORIN GROUP USA/LIVA NOVA USA, INC. SORIN AORTIC VALVE 07/12/2019
. OPEN PIVOT MECHANICAL HEART VALVE 12/12/2018
MEDTRONIC HEART VALVE DIVISION OPEN PIVOT MECHANICAL HEART VALVE 12/12/2018
MEDTRONIC HEART VALVES DIVISION AORTIC FLEX 07/12/2018
MEDTRONIC HEART VALVE DIVISION AORTIC AP 02/15/2018
MEDTRONIC HEART VALVES DIVISION HALL EASY FIT 04/20/2016
ST. JUDE MEDICAL PUERTO RICO, B.V. (CD) SJM MASTERS SERIES HEART VALVE W/TEFLON 02/01/2016
MEDTRONIC, INC. AORTIC AP 08/28/2015
MEDTRONIC, INC. OPEN PIVOT MECHANICAL HEART VALVE 03/03/2015
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