BEUDAMED
    10,000 results · 48ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

    FDA Pre-Market Approval
    FDA Class 3 ·DAKO TOP2A FISH PHARMDX KIT

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

    FDA Pre-Market Approval
    FDA Class 3 ·HER2 CISH pharmDX Kit

    Immunohistochemistry Antibody Assay, C-Kit

    FDA Pre-Market Approval
    FDA Class 3 ·C-KIT PHARMDX

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CLARITY /VITATRON DA+ C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+ T-SERIES/TOPAZ 3/VITA 2/VITA IPGS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CLARITY/VITATRON DA+C-SERIES/DIAMOND 3/JADE 3/RUBY 3/VITATRON DA+T-SERIES/TOPAZ 3/VITA 2/VITA IPGS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CLARITY/DA+ C-SERIES/T-SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/SELECTION AFM/TOPAZ 3/II/VITA/2

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CLARITY/DA+C & T SERIES/DIAMOND 3/II/JADE 3/II/RUBY 3/II/ SELECTION AFM/TOPAZ 3/II/VITA/VITA 2

    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 assays

    System, Test, Her-2/Neu, Ihc

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

    Transvenous Temporary Phrenic Nerve Stimulator

    FDA classification
    FDA Class 3 ·Transvenous Temporary Phrenic Nerve Stimulator

    Permanent Defibrillator Electrodes

    FDA classification
    FDA Class 3 ·Permanent Defibrillator Electrodes

    Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

    FDA classification
    FDA Class 3 ·Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

    Placental Alpha Microglobulin-1 Immunoassay

    FDA classification
    FDA Class 3 ·Placental Alpha Microglobulin-1 Immunoassay

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System

    Shunt, Portosystemic, Endoprosthesis

    FDA Pre-Market Approval
    FDA Class 3 ·WALLSTENT™ Endoprosthesis

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Solo Smart Stentless Heart Valve

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP System

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear