BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    QUANTIMETRIX AMMONIA CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE

    FDA 510(k)
    FDA Class 2 ·Dental

    NEON SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PLV-100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·May 14, 2014

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·November 11, 2010

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·January 14, 2013

    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