Product Code: DYE


Products Classified as DYE

834Replacement Heart-valveReplacement Heart Valve.

Total Product Life Cycle (TPLC) Devices

834Replacement Heart-valveReplacement Heart Valve.

FDA Consensus Standards

Replacement Heart-Valve [36801]21 CFR §870.3925 🔎
Replacement Heart-Valve [36800]21 CFR §870.3925 🔎

Pre-market Approvals for DYE

P040021SJM EPIC VALVE AND SJM EPIC SUPRA VALVESt. Jude Medical, Inc.
P870078Hancock Valved Conduit MOMedtronic, Inc.
P980043Hancock II Porcine BioprosthesisMedtronic, Inc.
P990064Mosaic Porcine Bioprosthetic Heart ValveMedtronic, Inc.
P860057Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Theon Pericardial Aortic Bioprosthesis with ThermaFix tisEDWARDS LIFESCIENCES, LLC.

Global Unique Device Identification Database

00613994796042replacement Heart-valve
00613994796035replacement Heart-valve
00613994796028replacement Heart-valve
00613994796011replacement Heart-valve
00613994772756replacement Heart-valve
00613994772749replacement Heart-valve
00613994760531replacement Heart-valve
00613994687036replacement Heart-valve
00613994686893replacement Heart-valve
00613994686756replacement Heart-valve
00613994578686replacement Heart-valve
00613994578679replacement Heart-valve
00613994578662replacement Heart-valve
00643169646568replacement Heart-valve
00643169646551replacement Heart-valve

Maude Adverse Events

CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-31
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-31
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-31
CARPENTIER-EDWARDS? PERIMOUNT MAGNA EASE? PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-31
MOSAICMEDTRONIC HEART VALVES DIVISION2020-03-31
MOSAICMEDTRONIC HEART VALVE DIVISION2020-03-31
HEART-VALVE, REPLACEMENTEDWARDS LIFESCIENCES2020-03-30
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-30
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-30
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-30
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-30
CARPENTIER-EDWARDS? PERIMOUNT THEON? PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-30
REPLACEMENT HEART VALVEEDWARDS LIFESCIENCES2020-03-30
CARPENTIER-EDWARDS PERIMOUNT AORTIC PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-30
CARPENTIER-EDWARDS? PERIMOUNT? PLUS PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-30
REPLACEMENT HEART VALVEEDWARDS LIFESCIENCES2020-03-30
HANCOCK II AORTIC CINCH 23MEDTRONIC HEART VALVES DIVISION2020-03-30
MOSAICMEDTRONIC HEART VALVES DIVISION2020-03-30
REPLACEMENT HEART VALVEEDWARDS LIFESCIENCES2020-03-30
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-30
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-27
HEART-VALVE, REPLACEMENTEDWARDS LIFESCIENCES2020-03-27
HEART-VALVE, REPLACEMENTEDWARDS LIFESCIENCES2020-03-27
HEART-VALVE, REPLACEMENTEDWARDS LIFESCIENCES2020-03-27
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-27
CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-27
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-27
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-27
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-27
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-27
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-27
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-27
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-27
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-27
REPLACEMENT HEART VALVEEDWARDS LIFESCIENCES2020-03-27
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-27
REPLACEMENT HEART VALVEEDWARDS LIFESCIENCES2020-03-27
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-27
EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-27
CARPENTIER-EDWARDS? PERIMOUNT? MAGNA MITRAL EASE? PERICARDIAL BIOPROSTHESESEDWARDS LIFESCIENCES2020-03-27
CARPENTIER-EDWARDS? PERIMOUNT MAGNA EASE? PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-27
CARPENTIER-EDWARDS? PERIMOUNT MAGNA? MITRAL PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-27
REPLACEMENT HEART VALVEEDWARDS LIFESCIENCES2020-03-27
REPLACEMENT HEART VALVEEDWARDS LIFESCIENCES2020-03-27
CARPENTIER-EDWARDS? PERIMOUNT THEON? PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-26
CARPENTIER-EDWARDS? PERIMOUNT THEON? PERICARDIAL BIOPROSTHESISEDWARDS LIFESCIENCES2020-03-26
MOSAIC AORTIC BIOPROSTHETIC HEART VALVEMEDTRONIC HEART VALVES DIVISION2020-03-26
HANCOCK II AORTIC BIOPROSTHETIC HEART VALVEMEDTRONIC HEART VALVES DIVISION2020-03-26
MOSAICMEDTRONIC HEART VALVE DIVISION2020-03-26
MOSAIC AORTIC BIOPROSTHETIC HEART VALVEMEDTRONIC HEART VALVE DIVISION2020-03-26
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