BEUDAMED
    10 results · 28ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Mobility Scooter (MS160A)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 21, 2024

    OPUS 5100 Diagnostic Doppler Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    QUANTEX MYOGLOBIN

    FDA 510(k)
    FDA Class 2 ·Immunology

    STONETOME STONE REMOVAL DEVICE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FDI·November 20, 2008

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011

    KAPPA 700 SR

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code NVZ·July 23, 2013

    STEALTH 32 LHOOK LAP ELEC PKG

    FDA Adverse Event
    Malfunction ·CONMED UTICA·Product code GEI·November 12, 2021

    STEALTH 32 LHOOK LAP ELEC PKG

    FDA Adverse Event
    Malfunction ·CONMED UTICA·Product code GEI·November 12, 2021

    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