BEUDAMED
    1,538 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Generator, Shock-Wave, For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·NIRFLEX PREMOUNTED CORONARY STENT SYSTEM

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE 2100 SYSTEM

    Lymph Node Location System During Sentinel Biopsy Procedure

    FDA Pre-Market Approval
    FDA Class 3 ·Magtrace® and Sentimag® Magnetic Locatization System (PUV)

    Lymph Node Location System During Sentinel Biopsy Procedure

    FDA Pre-Market Approval
    FDA Class 3 ·Magtrace and Sentimag Magnetic Locatization System (PUV)

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·EluNIR Ridaforolimus Eluting Coronary Stent System

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·BD 1% OVD (1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID)

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·NIRXCELL COCR CORONARY SENT ON RX

    System, Laser, Fiber Optic, Photodynamic Therapy

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)

    Stent, Superficial Femoral Artery, Drug-Eluting

    FDA Pre-Market Approval
    FDA Class 3 ·Zilver PTX Drug-Eluting Peripheral Stent

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (OVD)

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·CyPass Ultra System

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF RESTOR INTRAOCULAR LENS

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·HeartSine’s Samaritan® Public Access Automated External Defibrillators

    Aid, Surgical, Viscoelastic

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

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

    Stent, Iliac Vein

    FDA Pre-Market Approval
    FDA Class 3 ·Zilver Vena® Venous Self-Expanding Stent

    Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

    FDA Pre-Market Approval
    FDA Class 3 ·T-SPOT®.TB Test

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

    Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

    FDA Pre-Market Approval
    FDA Class 3 ·T-SPOT TB TEST