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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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145 records meeting your search criteria returned- Product Code: NPT Product Problem: Leak/Splash Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
EDWARDS LIFESCIENCES SAPIEN 3 TRANSCATHETER HEART VALVE 12/22/2023
EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VAL 06/09/2023
EDWARDS LIFESCIENCES COMMANDER DELIVERY SYSTEM 03/20/2023
EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VAL 12/23/2022
EDWARDS LIFESCIENCES LLC EDWARDS SAPIEN 07/15/2022
EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM 02/11/2022
EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM 09/24/2021
EDWARDS LIFESCIENCES EDWARDS SAPIEN XT TRANSCATHETER HEART VA 01/23/2021
EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VAL 11/20/2020
EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VAL 10/09/2020
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