BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    UROSCAN

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517159694·CoRoent® XLF, 8x18x55mm 10°

    T-Rex Standalone ALIF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SLEEP QUALITY

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 12, 2014

    STRATA II, ADJUSTABLE DELTA VALVE, SMALL

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·October 7, 2010

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·December 12, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015