BEUDAMED
    10,000 results · 40ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·DISCOVISC™ Ophthalmic Viscosurgical Device

    Immunocytochemistry Assay, P16/Ki-67

    FDA Pre-Market Approval
    FDA Class 3 ·CINtec PLUS Cytology

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Senza Spinal Cord Stimulation (SCS) System

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Saluda Medical Evoke SCS System

    Over-The-Counter Automated External Defibrillator

    FDA Pre-Market Approval
    FDA Class 3 ·HeartStart Home Defibrillator, HeartStart OnSite Defibrillator, HeartStart HS1 SMART Pads, Adult (M5071A), HeartStart HS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·ACRYSOF TORIC POSTERIOR CHANBER IOL, ACRYSOF TORIC SINGLE-PIECE NATURAL IOL, ACRYSOF IQ TORIC IOL & ACRYSOF TORIC IOL

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·BIOCOR/EPIC VALVE

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·PREMIER PACING SYSTEM

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE MITRAL BIOPROSTHESES, MODELS 7100 AND 7100TFX

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·ORCHESTRA PROGRAMMER

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Emblem Subcutaneous Implantable Cardioverter Defibrillator Pulse Gerator

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·ACTIVITRAX MODELS 8400, 8402, 8403

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC INTERSTIM SACRAL NERVE THERAPY SYSTEM

    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

    FDA Pre-Market Approval
    FDA Class 3 ·NEW JERSEY INTEGRATED KNEE REPLACEMENT SYSTEM

    Device, Removal, Pacemaker Electrode, Percutaneous

    FDA Pre-Market Approval
    FDA Class 3 ·ELCA and SLS/GlideLight Catheter

    Shockwave Intravascular Lithotripsy System

    FDA Pre-Market Approval
    FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Algovita Spinal Cord Stimulation System