BEUDAMED
    2,295 results · 17ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·AUTODELFIA HAFP KIT

    Prosthesis, Penis, Inflatable

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

    Biologic Material, Dental

    FDA Pre-Market Approval
    FDA Class 3 ·Straumann Emdogain

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·AED 3 Semi-Automatic, AED 3 Fully Automatic

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·STAARVISC, OPTIVISC, AND ANIKAVISC SODIUM HYALURONATE

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·APLIGRAF(R)

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·CHARITE ARTIFICIAL DISC

    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·UROLUME URETHRAL STENT

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR AHBS ASSAY

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Powerheart G5 AED

    Implanted Fecal Incontinence Device

    FDA Pre-Market Approval
    FDA Class 3 ·ACTICON ARTIFICIAL BOWEL SPHINCTER

    Device, Thermal Ablation, Endometrial

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

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP, Impella 5.0 and Impella LD

    Device, Thermal Ablation, Endometrial

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

    Prosthesis, Penis, Inflatable

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

    Stimulator, Electrical, Implantable, For Incontinence

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

    Microspheres Radionuclide

    FDA Pre-Market Approval
    FDA Class 3 ·TheraSphere

    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·UROLUME ENDOPROSTHESIS

    Temporary Non-Roller Type Right Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella RP System