BEUDAMED
    2 results · 56ms · 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 Status: Open, Classified ×

    O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.-Littleton·Product code OWB·April 26, 2024

    The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs. or greater and having an abdominal thickness greater than 16 cm and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.-Littleton·Product code OWB·July 25, 2023