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

    Implanted Brain Stimulator For Epilepsy

    FDA Pre-Market Approval
    FDA Class 3 ·NeuroPace® RNS® System

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·Oncomine Dx Target Test

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·ISOMED IMPLANTABLE INFUSION SYSTEMS

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

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Deep Brain Stimulation Therapy System for Parkinson's Disease

    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Bowel Programming Systems)

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    FDA Pre-Market Approval
    FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Urinary Programming Systems)

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEM

    Ophthalmic Sealant

    FDA Pre-Market Approval
    FDA Class 3 ·RESURE SEALANT

    Alfapump System

    FDA Pre-Market Approval
    FDA Class 3 ·alfapump System

    Sensor, Glucose, Invasive

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

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·SYNCHROMED, SYNCHROMED EL AND SYNCHROMED II IMPLANTABLE INFUSION SYSTEMS

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Selenia Dimensions 3D System.

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

    FDA Pre-Market Approval
    FDA Class 3 ·ASCENSION MCP