BEUDAMED
    2,346 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Device, Impotence, Mechanical/Hydraulic

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

    System, Laser, Photodynamic Therapy

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

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·3100 HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·THINPREP(R) 2000 SYSTEM

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·SYNVISC (HYLAN G-F 20

    Dressing, Wound And Burn, Interactive

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

    Reader, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·THINPREP IMAGING SYSTEM

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM

    Biologic Material, Dental

    FDA Pre-Market Approval
    FDA Class 3 ·EMDOGAIN GEL

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Cardinal Health Multifunctional Defibrillation Electrode

    Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

    FDA Pre-Market Approval
    FDA Class 3 ·AMS UROLUME ENDOPROSTHESIS

    Occluder, Internal Vessel, Temporary

    FDA Pre-Market Approval
    FDA Class 3 ·LEGOO ENDOVASCULAR OCCLUSION GEL

    Dressing, Wound And Burn, Interactive

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

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Artificial Urinary Sphincter

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella CP with SmartAssist System, Impella 5.5 with SmartAssist System

    Temporary Non-Roller Type Right Heart Support Blood Pump

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·ARROW MODEL 3000-16 CONSTANT FLOW IMPLANTABLE PUMP WITH BOLUS SAFETY VALVE

    Ventilator, High Frequency

    FDA Pre-Market Approval
    FDA Class 3 ·Model 3100A/B High Frequency Oscillatory Ventilator