BEUDAMED
    315 results · 26ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

    FDA Pre-Market Approval
    FDA Class 3 ·XPS™ with Steen Solution™ Perfusate

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·Atellica® IM Hepatitis B surface Antigen II (HBsll), Atellica® IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Con

    Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

    FDA Pre-Market Approval
    FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPARED FUSION DEVICE

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·CADENCE (R) TIERED THERAPY DEFIBRILLAATOR SYSTEM

    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

    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, Implantable, For Incontinence

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

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA Pre-Market Approval
    FDA Class 3 ·HER2 FISH PHARMDX KIT

    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.