BEUDAMED
    2,856 results · 29ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Bellafill Dermal Filler

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·FREEDOM DRIVER SYSTEM

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·X-70 SOFT CONTACT LENS

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Avalus Bioprosthesis

    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 ·Avalus Bioprosthesis and Avalus Ultra Bioprosthesis

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Bellafill Dermal Filler

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-HER2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·Ventana PD-Ll (SP263) Assay

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Alinity m HBV

    Covered Stent Vascular Connector, Hemodialysis Access Circuit

    FDA Pre-Market Approval
    FDA Class 3 ·EndoForce™ Connector for Endovascular Venous Anastomosis

    Artificial Heart

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

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Avalus

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·HANCOCK LOW POROSITY VALVED CONDUIT

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MMR RxDx Panel (Solid Tumors with dMMR status)

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Avalus Bioprosthesis

    Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

    FDA Pre-Market Approval
    FDA Class 3 ·UROVYSION BLADDER CANCER KIT ASSAY