BEUDAMED
    3,760 results · 30ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    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 CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)

    Replacement Heart-Valve

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

    Hepatitis Viral B Dna Detection

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA HER2 Dual ISH DNA Probe Cocktail

    Intraocular Lens

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

    Test, Urea Adult And Pediatric (Breath),

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

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Avalus Bioprosthesis

    Intraocular Lens

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

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·HANCOCK PORCINE BIOPROSTHETIC VALVED CONDUIT AND HANCOCK TROCAR BLADES AND HANDLE

    Replacement Heart-Valve

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

    Somatic Gene Mutation Detection System

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

    Immunohistochemistry Antibody Assay, C-Kit

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY Anti-c-KIT (9.7) 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

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY HER-2/NEU CONTROL SLIDES

    Aid, Surgical, Viscoelastic

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

    Artificial Heart

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

    Hepatitis Viral B Dna Detection

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

    Immunohistochemistry Antibody Assay, C-Kit

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