BEUDAMED
    2,487 results · 24ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·Axonics Sacral Neuromodulation System

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) (with and without InhibiZone)

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·Atellica IM Alpha Fetoprotein (AFP)

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·ENROUTE® Transcarotid Stent System

    Microspheres Radionuclide

    FDA Pre-Market Approval
    FDA Class 3 ·TheraSphereTM Y-90 Glass Microspheres System

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·ANGIOLINK VASCULAR CLOSURE SYSTEM

    Microspheres Radionuclide

    FDA Pre-Market Approval
    FDA Class 3 ·TheraSphere

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·Model 400 Implantable Infusion Pump

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·Axonics Sacral Neuromodulation System

    Oximeter, Fetal Pulse

    FDA Pre-Market Approval
    FDA Class 3 ·SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING

    Prosthesis, Penis, Inflatable

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 700 SERIES INFATABLE PENILE PROSTHESIS

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·Monovisc High Molecular Weight Hyaluronan

    Laparoscopic Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·Falope-Ring Band Contraceptive Tubal Occlusion System

    Biologic Material, Dental

    FDA Pre-Market Approval
    FDA Class 3 ·Straumann Emdogain

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur HBsAg/Confirmatory Readypack Reagents, Calibrators and Controls

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·LOTUS Edge Valve System

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·HYDRELLE

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·ORBERA Intragastric Balloon

    Stent, Urethral, Prostatic, Semi-Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·THE SPANNER TEMPORARY PROSTATIC STENT

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist