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

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    LIFECARE 75 CONTROLLER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Agilon Strip

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CATHETER BUBBLE STAND

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LEAD EXTRACTION BYRD POLYPROPYLENE EXTRA LONG DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VANDERGRIFT INC·Product code GCC·January 22, 2021

    SIGMA SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·June 13, 2014

    PINN MAR LIP LNR 28IDX48OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWY·January 2, 2013

    REALIZE ADJ GASTRIC BAND-C

    FDA Adverse Event
    Malfunction ·OBTECH MEDICAL SARL_·Product code LTI·November 8, 2010

    LEAD EXTRACTION BYRD POLYPROPYLENE DILATOR SHEATH SET

    FDA Adverse Event
    Malfunction ·COOK VANDERGRIFT INC·Product code GCC·March 9, 2022

    GYC-1000

    FDA Adverse Event
    Malfunction ·NIDEK CO., LTD.·Product code HQF·June 18, 2015

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012