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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
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7 records meeting your search criteria returned- Product Code: NPT Product Problem: Misassembly by Users Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
EDWARDS LIFESCIENCES SAPIEN 3 TRANSCATHETER HEART VALVE 07/26/2023
EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEA 03/08/2023
EDWARDS LIFESCIENCES LLC EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEA 05/26/2022
EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEATH VAL 03/03/2022
EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER 12/13/2021
EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEA 10/08/2021
MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE 07/16/2021
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