BEUDAMED
    2,317 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·MENICON SF-P (MELAFOCON A) CONTACT LENS

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·ThinPrep Genesis Processor

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·PREVELLE SILK

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·IMPELLA 2.5 SYSTEM

    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

    FDA Pre-Market Approval
    FDA Class 3 ·PROSORBA COLUMN

    Device, Thermal Ablation, Endometrial

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

    Dressing, Wound And Burn, Interactive

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne Liquid CDx (F1LCDx)

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·IMPELLA 2.5 SYSTEM

    Stimulator, Electrical, Implantable, For Incontinence

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

    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