BEUDAMED
    2,350 results · 28ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: FDA Class 3 ×

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprothesis

    Replacement Heart-Valve

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

    Replacement Heart-Valve

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

    Mitral Valve Repair Devices

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

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Sapien 3 Transcatheter Heart Valve and Sapien 3 Ultra Transcatheter Heart Valve

    Aortic Valve, Prosthesis, Percutaneously Delivered

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

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS S.A.V. AORTIC PORCINE BIOPROSTHESIS

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Commander Delivery System

    Aortic Valve, Prosthesis, Percutaneously Delivered

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

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SYNCARDIA CAMPANION 2 DRIVER SYSTEM

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM RETROFLEX BALLOON CATHETER EDWARDS

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

    Aortic Valve, Prosthesis, Percutaneously Delivered

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

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·prodisc C Total Disc Replacement

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·PERIMOUNT, PERIMOUNT MAGNA AND PERIMOUNT PLUS PERCARDIAL BIOPROSTHESES

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·SAPIEN 3 Transcatheter Heart Valve and Accessories

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Clareon PanOptix Pro Trifocal Intraocular Lens (IOL), Clareon PanOptix Pro Trifocal Toric IOLs, Clareon PanOptix Pro Tr

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS MODEL 2500P

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Certitude Introducer Sheath Set