BEUDAMED
    10,000 results · 49ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·Dexcom G4 Platinum/G5 Mobile Continuous Glucose Monitoring System

    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

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead

    Stimulator, Hypoglossal Nerve, Implanted, Apnea

    FDA Pre-Market Approval
    FDA Class 3 ·Inspire Upper Airway Stimulation System

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·therascreen KRAS RGQ PCR Kit

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·PROVISC™ Ophthalmic Viscosurgical Device

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·SNS Bowel Neurostimulators Implantable InterStim

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Frequency 55 (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CapSure Sense Leads

    Absorbable Collagen Hemostatic Agent With Thrombin

    FDA Pre-Market Approval
    FDA Class 3 ·HEMOBLAST Bellows

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·Anthem,  Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional)

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·TactiFlex SE Ablation Catheter, Sensor Enabled

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·Carbomedics Prosthetic Heart Valve, Carbomedics Supra-Annular Prosthetic Heart Valve (Top Hat), Carbo-Seal Ascending Aor

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

    Iliac Covered Stent, Arterial

    FDA Pre-Market Approval
    FDA Class 3 ·GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·DuraSeal Dural Sealant System

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·PMMA SINGLE-PIECE POSTERIOR CHAMBER IOLS