BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    MON-A-THERM MYOCARDIAL TEMP. SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IPL THERAPY SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDS-4 NEUROMUSCULAR STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 21, 2026

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 26, 2014

    RESTORE PRIME

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 8, 2012

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·August 25, 2010

    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