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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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86 records meeting your search criteria returned- Product Code: NPT Patient Problem: No Patient Involvement Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
EDWARDS LIFESCIENCE COMMANDER DELIVERY SYSTEM 03/05/2021
EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET 03/05/2021
EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER 02/05/2021
MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS 11/06/2020
MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS 11/04/2020
MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM 10/29/2020
MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM 10/28/2020
MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM 10/23/2020
MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS 10/20/2020
MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE 10/20/2020
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