BEUDAMED
    1,920 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Artificial Heart

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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·UV-PMMA ALTERNATE VENDOR /UV ABSORBING IOL

    Intraocular Lens

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

    Aid, Surgical, Viscoelastic

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

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·ARTEFILL

    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

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System - Companion 2 Driver System

    Intraocular Lens

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

    Immunohistochemistry Antibody Assay, C-Kit

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

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL UP350 UV/ABSORBING POSTERIOR CHAMBER IOL

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 721A ULTRAVIOLET LIGHT-ABSORBING LENS (POST)

    Immunocytochemistry Assay, P16/Ki-67

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

    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 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 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Hepatitis Viral B Dna Detection

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

    Intraocular Lens

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

    Implant, Dermal, For Aesthetic Use

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