BEUDAMED
    5,451 results · 50ms · Sources: EU EUDAMED, US FDA

    BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522

    FDA 510(k)
    FDA Class 2 ·Microbiology

    LEGIONELLA PNEUMOPHILA IGG/IGM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    TRU Legionella

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BINAX LEGIONELLA URINARY ANTIGEN EIA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus 22 Cochlear Implant Systems

    OvuSense Fertility Monitor System. M026 OvuCore Vaginal Sensor, M426 OvuFirst Skin Worn Sensor and M032 OvuSense App.

    FDA registration
    viO HealthTech Limited·1 product·🇬🇧 United Kingdom

    RADIFY Triage

    FDA registration
    ENVISIONIT DEEP AI Ltd·1 product·🇬🇧 United Kingdom

    Helix Genetic Health Risk App for late-onset Alzheimer’s disease

    FDA 510(k)
    FDA Class 2 ·Immunology

    t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus Hybrid Cochlear Implant

    Implant, Auditory Brainstem

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus Auditory Brainstem Implant

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus 24 Cochlear Implant Systems

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC GEM III AT WITH APP, DEVICE MODEL 7276 AND SOFTWARE MODEL 9974

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Eterna Spinal Cord Simulation Implantable Pulse Generator (IPG) and NeuroSphere Digital Health App

    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

    FDA Pre-Market Approval
    FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

    FDA Pre-Market Approval
    FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System; FreeStyle Libre 14 Day Flash Glucose Monitoring System

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Prospera SCS System, Resilience Surgical Lead, Embrace One

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM