BEUDAMED
    2,856 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Intraocular Lens

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

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BSD 1000 HYPERTHERMIA SYSTEM

    Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL

    Replacement Heart-Valve

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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 727A POSTERIOR CHAMBER INTRAOCULAR LENSES

    Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MMR RxDx Panel, VENTANA ANTI-MLH1 (M1), VENTANA ANTI-MSH6 (SP93), VENTANA ANTI-MSH2 (G219-1129), VENTANA ANTI-PM

    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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL UV65 SERIES ANTERIOR CHAMBER LENSES

    Intraocular Lens

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

    Artificial Heart

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

    Immunohistochemistry Antibody Assay, C-Kit

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

    Artificial Heart

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

    Device, Hemostasis, Vascular

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

    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)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·IOPTEX PMMA ANTERIOR CHAMBER IOLS

    System, Rf/Microwave Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·BSD 1000 HYPERTHERMIA SYSTEM

    Artificial Heart

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