BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    FETALFLEX FETAL ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Q-Switched Nd:YAG Laser System

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

    SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200

    FDA 510(k)
    FDA Unclassified ·Unknown

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 13, 2014

    ZIMMER M/L TAPER MODULAR FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER INC.·Product code JDI·October 12, 2010

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC-BROOKFIELD·Product code CFR·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