2,350 results · 32ms · Sources: EU EUDAMED, US FDA

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Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS(R) PERICARDIAL BIOPROSTHESIS, MODEL 2700

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-T) System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Aspheric UV Absorbing IOL, Clareon Aspheric UV Absorbing IOL with the AutonoMe Automated Preloaded Delivery Devi

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRODISC -C TOTAL DISC REPLACEMENT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards INTUITY Elite Valve

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval
FDA Class 3 ·PRODISC C TOTAL DISC REPLACEMENT

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS INTUITY Elite Valve System

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·NOVAFLEX+ DELIVERY SYSTEM, ASCENDRA+ DELIVERY SYSTEM, EDWARDS EXPANDABLE INTRODUCER SHEATH SET, ASCENDRA+ INTRODUCER SHE

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval
FDA Class 3 ·AUGMENT BONE GRAFT

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC)

Percutaneously Delivered Prostheses And Tricuspid Valves

FDA Pre-Market Approval
FDA Class 3 ·Edwards EVOQUE Tricuspid Valve Replacement System

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES