BEUDAMED
    1,038 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity Sphere, Biofinity Toric, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Contact

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne Liquid CDx

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SILICONE POSTERIOR CHAMBER INTRACULAR LENSES IOL MODEL 127(920)

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne Liquid CDx

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·LeukoStrat® CDx FL T3 Mutation Assay

    Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System (OCS™) Liver

    Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System (OCS™) Lung System

    Organ Care System (Ocs) Heart System

    FDA Pre-Market Approval
    FDA Class 3 ·Organ Care System (OCS) Heart System

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·BIOELECTRON SPINALPAK II SPINE FUSION STIMULATOR

    HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    CERYX6, 611, CERYX 3 311 & CERYX 1 111

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    TP 1

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODIFIED J & C LOOP MODEL PA36

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·VISTAKON (ETAFILCON A) BRAND CONTACT LENSES

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·VISTAKON (senofilcon A) Brand Contact Lenses

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Lenstec Softec HD aspheric posterior chamber intraocular lens

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·S.M.A.R.T. RADIANZ Vascular Stent System

    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

    FDA Pre-Market Approval
    FDA Class 3 ·EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM

    Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

    FDA Pre-Market Approval
    FDA Class 3 ·Trufill n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·MYNXGRIP AND MYNX ACE VASCULAR CLOSURE DEVICE