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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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9 records meeting your search criteria returned- Product Code: KRH Product Problem: Calcified Report Date From: 01/1/2014
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ManufacturerBrand NameDate Report Received
MEDTRONIC HEART VALVES DIVISION CG FUTURE BAND 09/06/2019
MEDTRONIC HEART VALVES DIVISION BAND 620BG31 DURAN ANCORE ANNULOPLASTY C 08/01/2019
MEDTRONIC HEART VALVES DIVISION SIMULUS FULLY FLEXIBLE ANNULOPLASTY BAND 12/08/2017
MEDTRONIC HEART VALVE DIVISION RING PROFILE 3D 28MM 11/20/2017
EDWARDS LIFESCIENCES COSGROVE-EDWARDS ANNULOPLASTY SYSTEM 09/21/2017
MEDTRONIC HEART VALVES DIVISION DURAN ANCORE RING 01/10/2017
MEDTRONIC HEART VALVES DIVISION RING ANNULOPLSTY TRICUSP CONTOUR 3D 28MM 10/19/2016
MEDTRONIC HEART VALVES DIVISION CG FUTURE BAND 06/09/2016
EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY R 03/02/2016
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