BEUDAMED
    8 results · 19ms · 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.

    MOP CATHETER

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

    ASTRA TECH IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Smart Peak Flow Meter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWQ·June 11, 2009

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 24, 2014

    NX3 DUAL CURE CLEAR

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·November 4, 2010

    XENFORM

    FDA Adverse Event
    Other ·TEI BIOSCIENCES INC.·Product code FTM·December 6, 2012

    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