BEUDAMED
    1,920 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Immunocytochemistry Assay, P16/Ki-67

    FDA Pre-Market Approval
    FDA Class 3 ·CINtec PLUS Cytology

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·Ventana PD-L1 (SP263) Assay

    Implant, Dermal, For Aesthetic Use

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

    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

    Intraocular Lens

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

    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 ·C-Kit pharmDx

    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 ·ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL UP350 - POSTERIOR CHAMBER INTRAOCULAR LENS

    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

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·HANCOCK BIOPROSTHESIS MODELS 242,342,343C,342R

    Artificial Heart

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

    System, Test, Her-2/Neu, Ihc

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

    Hepatitis Viral B Dna Detection

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

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

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

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) 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 ·MODELS 019B, 019C, 019E, 019F, 019J, & 019K

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAYANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY