BEUDAMED
    2,856 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Avalus Bioprosthesis

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODELS U260,U360,U360N,U365,U370,&UP383 LENSES

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·HANCOCK PORCINE BIOPROSTHETIC VALVED CONDUIT AND HANCOCK TROCAR BLADES AND HANDLE

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·Hancock Modified Orifice Valved Conduit

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·Closer Vascular Sealing System (VSS)

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Abbott RealTime IDH2

    Immunohistochemistry Antibody Assay, C-Kit

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY Anti-c-KIT (9.7) Primary Antibody

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·Closer Vascular Sealing System (VSS)

    Hepatitis Viral B Dna Detection

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

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Avalus™ Bioprosthesis

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY HER-2/NEU CONTROL SLIDES

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·AMO(R) VITRAX(R) VISCOELASTIC SOLUTION

    Artificial Heart

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

    Hepatitis Viral B Dna Detection

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

    Immunohistochemistry Antibody Assay, C-Kit

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY Anti-c-KIT (9.7) Primary Antibody

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ONE PIECE (NON-CM) TM POSTERIOR CHAMBER LENSES

    Artificial Heart

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

    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

    Artificial Heart

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

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA PD-LI (SP263) Assay