BEUDAMED
    2,709 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Orbera Intragastric Balloon

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

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 Artifical Urinary Sphinchter

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Powerheart G5 Automated External Defibrillator

    Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

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

    Implanted Fecal Incontinence Device

    FDA Pre-Market Approval
    FDA Class 3 ·ACTICON NEOSPHINCTER

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·AUTODELFIA HAFP KIT

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·IMPELLA VENTRICULAR SUPPORT SYSTEMS

    Generator, Shock-Wave, For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM

    Dressing, Wound And Burn, Interactive

    FDA Pre-Market Approval
    FDA Class 3 ·APLIGRAF

    Continuous Glucose Monitor, Implanted, Adjunctive Use

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

    Acid, Hyaluronic, Intraarticular

    FDA Pre-Market Approval
    FDA Class 3 ·SYNVISC

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·BOND ORACLE HER2 IHC SYSTEM

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·Onclarity HPV Assay

    Microspheres Radionuclide

    FDA Pre-Market Approval
    FDA Class 3 ·TheraSphere

    Stimulator, Electrical, Implantable, For Incontinence

    FDA Pre-Market Approval
    FDA Class 3 ·Axonics Sacral Neuromodulation System

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·AMS 800 ARTIFICIAL URINARY SPHINCTER

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·ANGIOSEAL VASCULAR CLOSURE DEVICE