BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    AMERICANA HIP PROTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RANDOX C-REACTIVE PROTEIN CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K

    FDA 510(k)
    FDA Class 2 ·Immunology

    KAPPA 900 DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·December 13, 2010

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 9, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·December 27, 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