BEUDAMED
    2,856 results · 19ms · 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

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

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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL AC10 & AC20 IOLS

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

    FDA Pre-Market Approval
    FDA Class 3 ·INFORM HER2 DUAL ISH DNA PROBE COCKTAIL

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

    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

    System, Test, Her-2/Neu, Ihc

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

    Artificial Heart

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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL UV65 ANTERIOR CHAMBER INTRAOCULAR LENS

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY HER 2 (CLONE CB11)

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·VITRAX OPHTHALMIC SURGICAL AID

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 721A ULTRAVIOLET LIGHT-ABSORBING LENS (POST)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODELS 019B, 019C, 019E, 019F, 019J, & 019K

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·HANCOCK PORCINE BIOPROSTHESIS

    Artificial Heart

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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·UV-PMMA ALTERNATE VENDOR /UV ABSORBING IOL

    Intraocular Lens

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

    Aid, Surgical, Viscoelastic

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

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·ARTEFILL

    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