BEUDAMED
    48 results · 25ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 2 ×

    IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

    GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Full Field Digital, System, X-Ray, Mammographic

    FDA Pre-Market Approval
    FDA Class 2 ·FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE

    Non-Invasive Central Venous Manometer

    FDA classification
    FDA Class 2 ·Non-Invasive Central Venous Manometer

    Vibratory Counter-Stimulation

    FDA classification
    FDA Class 2 ·Vibratory Counter-Stimulation

    Holding Chambers, Direct Patient Interface

    FDA classification
    FDA Class 2 ·Holding Chambers, Direct Patient Interface