BEUDAMED
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    EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET

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

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209123575·

    MEDCARE GENERAL PURPOSE TRAY

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    C-LOOPS

    FDA 510(k)

    SCRDRIVER SHAFT 2.4 SHORT SELF-HOLDING F

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·February 3, 2023

    FREESTYLE

    FDA Adverse Event
    Malfunction ·Product code LFR·June 6, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 3, 2012

    SURG PAT XRAY 1/2X2

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF, INC.·Product code HBA·September 7, 2010

    VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·February 19, 2020