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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 
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161 records meeting your search criteria returned- Product Code: NPT Product Problem: Activation, Positioning or Separation Problem Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
EDWARDS LIFESCIENCES AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY 08/12/2023
EDWARDS LIFESCIENCES LLC SAPIEN 3 VALVE 08/12/2023
EDWARDS LIFESCIENCES LLC SAPIEN 3 ULTRA SYSTEM 06/30/2023
MEDTRONIC HEART VALVES DIVISION / COREV EVOLUT FX DELIVERY CATHETER SYSTEM 11/21/2022
MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS 06/03/2022
MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE 10/19/2021
EDWARDS LIFESCIENCES LLC EDWARDS COMMANDER DELIVERY SYSTEM 09/17/2021
EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN VALVE 08/31/2021
MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE 04/28/2021
BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE SYSTEM 12/04/2020
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