BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    MPC-1000 INJECTION CAP/PLUG

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NICOLET VOYAGEUR

    FDA 510(k)
    FDA Class 2 ·Neurology

    KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CORTEX SCREW

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·January 22, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010

    IDENTITY ADX VDR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 10, 2014

    HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·August 16, 2018

    dS Breast 7ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024