BEUDAMED
    2,783 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Artificial Heart

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

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS INTUITY Elite 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 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX

    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

    Bone Grafting Material, Dental, With Biologic Component

    FDA Pre-Market Approval
    FDA Class 3 ·GEM 21S GROWTH FACTOR ENHANCED MATRIX

    Aortic Valve, Prosthesis, Percutaneously Delivered

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

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS

    Replacement Heart-Valve

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

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Intuity Valves and Delivery Systems

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·Total Artificial Heart

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, PERIMOUNT Theon/Magna Pericardial Aortic Bioprosthesis wi

    Aortic Valve, Prosthesis, Percutaneously Delivered

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

    Biologic Material, Dental

    FDA Pre-Market Approval
    FDA Class 3 ·GEMS 21S (GROWTH-FACTOR ENHANCED MATRIX)

    Aortic Valve, Prosthesis, Percutaneously Delivered

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

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·MENTOR MEMORYSHAPE BREAST IMPLANTS

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·Clareon PanOptix Trifocal Hydrophobic IOL, and Clareon PanOptix Trifocal Hydrophobic IOL with the AutonoMe Automated Pre

    Replacement Heart-Valve

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