BEUDAMED
    1,920 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    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

    Intraocular Lens

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

    Immunohistochemistry Assay, Antibody, Met

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

    System, Test, Her-2/Neu, Ihc

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

    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

    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

    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 UV65 SERIES ANTERIOR CHAMBER LENSES

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER

    System, Test, Her-2/Neu, Ihc

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

    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

    Immunocytochemistry Assay, P16/Ki-67

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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL UPB350S POSTERIOR CHAMBER INTRAOCULAR LENS

    Aid, Surgical, Viscoelastic

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