BEUDAMED
    7 results · 20ms · 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 ×

    Edge Digital Flat Panel X-ray Detector

    FDA 510(k)
    FDA Class 2 ·Radiology

    50W CERALAS D 1950NM DIODE LASER

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

    STAXX(R) XD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRANETICS LASER SHEATH II

    FDA Adverse Event
    Death ·SPECTRANETICS CORP.·Product code MFA·July 20, 2011

    DELTA CER HEAD 12/14 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code LZO·June 17, 2013

    PUMP MMT-712EWS PRDGM INSULIN SK ZH

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·September 19, 2008

    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