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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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8 records meeting your search criteria returned- Product Code: NPT Product Problem: Noise, Audible Report Date From: 01/1/2018
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ManufacturerBrand NameDate Report Received
MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM 10/07/2022
BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE SYSTEM 07/28/2020
EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VAL 02/24/2020
EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSYTEM 11/13/2019
MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM 02/20/2019
MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM 09/20/2018
EDWARDS LIFESCIENCES EDWARDS COMMANDER DELIVERY SYSTEM 08/31/2018
MEDTRONIC HEART VALVES DIVISION ENVEO R DELIVERY SYSTEM 07/24/2018
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