BEUDAMED
    872 results · 27ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Mr-Guided Focused Ultrasound System

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE

    Drug-Eluting Sinus Stent

    FDA Pre-Market Approval
    FDA Class 3 ·PROPEL

    Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

    FDA Pre-Market Approval
    FDA Class 3 ·NeuRX Diaphragm Pacing System (DPS)

    Implant, Hearing, Active, Middle Ear, Partially Implanted

    FDA Pre-Market Approval
    FDA Class 3 ·VIBRANT SOUNDBRIDGE

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·JUVEDERM ULTRA XC INJECTABLE GEL

    Intracranial Coil-Assist Stent

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

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·POSTERIOR CHAMBER INTRAOCULAR LENSES (TIER A SUBMISSION)

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·CLARION CII BIONIC EAR, HIFOCUS ELECTRODE WITHOUT POSITIONER (MODEL AB-5100H-11A) & HIRES SOFTWARE (MODEL CI-6055)

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·LIFEPAK® CR2 Defibrillator

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·WAVELIGHT EX500 LASER SYSTEM

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·WAVELIGHT EX500 LASER SYSTEM

    Transcatheter Septal Occluder

    FDA Pre-Market Approval
    FDA Class 3 ·AMPLATZER PFO OCCLUDER

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·MODIFIED C-LOOP, UV-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

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

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Pipeline Flex Embolization Device

    Intraocular Lens

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

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·LASERSCAN LSX EXCIMER LASER SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·HYDROVIEW COMPOSITE HYGROGEL FOLDABLE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR (IOL)

    Implant, Corneal, Refractive

    FDA Pre-Market Approval
    FDA Class 3 ·INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF SINGLE-PIECE POSTERIOR CHAMBER IOL