BEUDAMED
    7 results · 33ms · Sources: EU EUDAMED, US FDA

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    DI CUSTOM IN THE EAR AND IN THE CANAL

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·January 17, 2013

    MAXIMO II DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010

    ENDURITY DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014

    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