BEUDAMED
    3,122 results · 17ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT Total PSA

    Leadless Pacemaker

    FDA Pre-Market Approval
    FDA Class 3 ·Micra AV TPS

    System, Test, Tumor Marker, For Detection Of Bladder Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare HVAD System

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·LIFESTENT VASCULAR STENT SYSTEMS

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·XACT CAROTID STENT SYSTEM

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·GUARDIAN RT

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·MONOPREP PAP TEST

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·QUANTIFERON TB GOLD

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·SUPERA PERIPHERAL STENT SYSTEM

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT CORE-M

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Relay Thoracic Stent-Graft With Plus Delivery System

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Secura DR ICD, Maximo II DR ICD, Protecta XT DR ICD, Protecta DR ICD, Secura VR ICD, Maximo II VR ICD, Protecta XT VR IC

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS Symfony Toric Extended Range of Vision IOLs

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·INTERSTIM MODEL 3023 AND TRANSCEND MODEL 3726 IMPLANTABLE NEUROSTIMULATORS

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Valiant Navion Thoracic Stent Graft System

    Device, Dermal Replacement

    FDA Pre-Market Approval
    FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED (IDRT-TS)

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE LEAD

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS