BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    AllTest Fentanyl Rapid Test (Urine)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ELECYS SHBG CALCHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Medical Surgical Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·October 14, 2014

    CURRENT PLUS VR

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 1, 2011

    VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAM·July 17, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022