BEUDAMED
    5 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Completed × Clear all

    Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388

    FDA Enforcement
    Class II ·Completed·Invivo Corporation·November 21, 2018

    Discovery NM/CT 670 Pro, model 5376204-70-54

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·December 19, 2018

    Discovery NM/CT 670 ES, model 5376204-70-57

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·December 19, 2018

    Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

    FDA Enforcement
    Class II ·Completed·GE Healthcare, LLC·December 19, 2018

    Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

    FDA Enforcement
    Class II ·Completed·Bio-Rad Labs·May 6, 2020