BEUDAMED
    2,856 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Hepatitis Viral B Dna Detection

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

    Intraocular Lens

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

    Immunohistochemistry Antibody Assay, C-Kit

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBITT MONOCLONAL PRIMARY ANTOBODY

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·ARTEFILL

    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) PRIMARY ANTIBODY

    Implant, Dermal, For Aesthetic Use

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

    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

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·HANCOCK APICAL LEFT VENTRICLE CONNECTOR

    Artificial Heart

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

    Test, Urea Adult And Pediatric (Breath),

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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·CM(TM) LENSES

    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

    System, Test, Her-2/Neu, Ihc

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

    Intraocular Lens

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

    System, Test, Her-2/Neu, Ihc

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

    Test, Urea Adult And Pediatric (Breath),

    FDA Pre-Market Approval
    FDA Class 3 ·PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·Total Artificial Heart

    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 ·PPATHWAY Anti-HER-2/NEU (4B5) Rabbit Monoclonal Primary Antibody