BEUDAMED
    10,000 results · 50ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·METHAFILCON A SOFT HYDROPHILIC EXTENDED WEAR CONTACT LENSES

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, PERCIVA, RESONATE

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·iPro2 CGM System with Enlite Sensor

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·EverFlex™ Self-Expanding Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery Syste

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·Sodium Hyaluronate OphthalmicViscoelastic Devices (OVD), Healon PRO, Healon GV PRO, Healon5 PRO and Healon Duet PRO Dual

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·INNOVA Vascular Self-Expanding Stent System

    Sealant, Dural

    FDA Pre-Market Approval
    FDA Class 3 ·DuraSeal Exact Spinal Sealant (3mL), DuraSeal Exact Spinal Sealant (5mL)

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CapSureFix Novus Lead

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

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

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate II™ Left Ventricular Assist System

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

    FDA Pre-Market Approval
    FDA Class 3 ·PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·CAPSURE/VITATRON CRYSTALINE/EXCELLENCE+/EXCELLENCE PS+

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·TELIGEN

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·PRODISC-C TOTAL DISC REPLACEMENT

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Restore Spinal Cord Stimulation Systems

    Shunt, Portosystemic, Endoprosthesis

    FDA Pre-Market Approval
    FDA Class 3 ·GORE VIATORR TIPS Endoprosthesis

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·INGEVITY MRI Passive Fixation Leads, INGEVITY non-MRI Passive Fixation Leads

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus 24 Cochlear Implant System

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Radiesse Injectable Implant