BEUDAMED
    2,762 results · 26ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·THINPREP PROCESSORS

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·oncoRevealTM CDx

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

    FDA Pre-Market Approval
    FDA Class 3 ·HeartLight X3 Endoscopic Ablation System

    Stent, Carotid

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

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIVISC

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

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA Centaur HBc Total Readypack Reagents and Quality COntrol Materials

    Biologic Material, Dental

    FDA Pre-Market Approval
    FDA Class 3 ·STRAUMANN ENDOGAIN, 0.15 ML, 075.099, STRAUMANN ENDOGAIN, 0.3 ML, 075.113, STRAUMANN ENDOGAIN, 0.7 ML, 075.115

    Stimulator, Electrical, Implantable, For Incontinence

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

    System, Laser, Photodynamic Therapy

    FDA Pre-Market Approval
    FDA Class 3 ·BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·ORTHOVISC SODIUM HYALURONATE

    Biologic Material, Dental

    FDA Pre-Market Approval
    FDA Class 3 ·STRAUMANN EMDOGAIN

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 URINARY CONTROL SYSTEM

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·Avitene™ Microfibrillar Collagen Hemostat

    Glue, Surgical, Arteries

    FDA Pre-Market Approval
    FDA Class 3 ·BioGlue Surgical Adhesive

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·X Series and Propaq MD

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·On X Prosthetic Heart Valve Ascending Aortic Prothesis

    Stent, Carotid

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

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·DANKER SILICONE LENS (DIMEFOCON-A)

    Reader, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·REVIEW SCOPE MANUAL

    Prosthesis, Penis, Inflatable

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