659 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES
CARPENTIER-EDWARDS PERIMOUNT MAGNA AND MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code DYE·October 4, 2013
SEE H10
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DYE·August 29, 2014
SEE H10
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·April 15, 2014
SEE H11
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·July 23, 2024
CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·May 14, 2019
SEE H10
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·September 1, 2017
SEE H10
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·February 18, 2015
SEE H10.
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·September 15, 2023
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT PERICARDFIAL AORTIC BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CAPENTIER-EDWARDS PERIMOUNT THEON, THEON PSR, MAGNA, MAGNA EASE, PERICARDIAL AORTIC BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESES DEVICE FAMILIES
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700TFX, 2800TFX, 3000TFX, AND 6900PTX
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT PERICARDIIAL AORTIC BIOPROSTHESIS, THEON PERICARDINAL AORTIC BIOPROSTHESIS WITH THERMAFIX T
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS, MODEL 3000 AORTIC
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Carpentier-Edwards PERIMOUNT Family of Pericardial Bioprostheses
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS