BEUDAMED
    2,856 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Replacement Heart-Valve

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

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MMR RxDx Panel

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ONE PIECE CM (R) POS.CHAMBER INTRAOCULAR LENSES

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·PyloPlus UBT System

    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

    Somatic Gene Mutation Detection System

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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL UP330F UV/ABSORBING POSTERIOR CHAMBER IOL

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·CLOSER VASCULAR SEALING SYSTEM

    Replacement Heart-Valve

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

    Immunohistochemistry Antibody Assay, C-Kit

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) 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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·CEEON HEPARIN SURFACE MODIFIED (HSM) UV LIGHT-ABSORBING POSTERIOR CHAMBER IOLS

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic Avalus Bioprosthesis, Model 400

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MMR RxDx Panel

    Intraocular Lens

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

    Implant, Dermal, For Aesthetic Use

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

    Immunohistochemistry Assay, Antibody, Folr1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA FOLR1 (FOLR-2.1) RxDx Assay

    Artificial Heart

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

    Artificial Heart

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

    Replacement Heart-Valve

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