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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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4 records meeting your search criteria returned- Product Code: KRH Product Problem: Structural Problem Report Date From: 01/1/2015
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ManufacturerBrand NameDate Report Received
EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PHYSIO II ANNULOPLAST 10/12/2018
EDWARDS LIFESCIENCES ANNULOPLASTY RING 08/13/2018
MEDTRONIC HEART VALVE DIVISION BAND 620BG23 DURAN ANCORE ANNULOPLASTY C 11/20/2017
MEDTRONIC HEART VALVES DIVISION RING PROFILE 3D 28MM 07/27/2016
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