BEUDAMED
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    MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH,

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BABY DOPPLEX 4002-TWINS, MODEL BD4002

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 23, 2026

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 22, 2013

    ROTATING CONTINUOUS FLOW INNER SHEATH

    FDA Adverse Event
    Malfunction ·GYRUS ACMI INC.·Product code FDS·August 12, 2014

    DEPUY

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KXA·April 23, 2011

    NIBP CUFFS

    FDA Adverse Event
    Injury ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code OED·August 8, 2025

    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