BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    OVUTIME OVULATION PREDICTOR TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209116034·

    Carestream DRX-1 System with DRX Plus 4343 Detectors

    FDA 510(k)
    FDA Class 2 ·Radiology

    AMBU MARK IV BABY RESUSCITATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM

    FDA Adverse Event
    Injury ·ACCURAY, INC·Product code IYE·May 22, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 30, 2012

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 22, 2010

    Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·July 10, 2024

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015