BEUDAMED
    3,496 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

    FDA Pre-Market Approval
    FDA Class 3 ·ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM

    Intraocular Lens

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

    Implant, Hearing, Active, Middle Ear, Partially Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·VIBRANT D SOUNDBRIDGE SYSTEM

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF UV-ABSORBING PMMA SINGLE-PIECE ANTERIOR CHAMBER

    Generator, Shock-Wave, For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·EMS SWISS DOLORCLAST

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF UV-ABSORBING MULTI-PIECE PC IOL

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C

    Sensor, Glucose, Invasive, Non-Adjunctive

    FDA Pre-Market Approval
    FDA Class 3 ·Simplera™ System

    Aspiration Therapy System

    FDA Pre-Market Approval
    FDA Class 3 ·AspireAssist

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS

    Femtosecond Laser System For Refractive Correction

    FDA Pre-Market Approval
    FDA Class 3 ·VISUMAX FEMTOSECOND LASER

    Intracranial Coil-Assist Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Neuroform Atlas® Stent System

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Surpass Streamline Flow Diverter

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)

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

    FDA Pre-Market Approval
    FDA Class 3 ·EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·OmniaSecure™ MRI SureScan™ Lead Model 3930M

    Wearable Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati

    Generator, Shock-Wave, For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·ORBASONE PAIN RELIEF SYSTEM

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT