BEUDAMED
    9 results · 35ms · Sources: EU EUDAMED, US FDA

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    HUDSON BRACE W/BURRS

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER

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

    CleverLock Guidewire Locking Device and Biopsy Cap

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

    STEAM STER LOCKS ORANGE

    FDA Adverse Event
    Injury ·AESCULAP INC·Product code KCT·October 12, 2016

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 24, 2014

    PUMP MMT-723NAS PRDGM INSULIN SMOKE EN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·October 29, 2010

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·December 28, 2012

    STEAM STER LOCKS ORANGE

    FDA Adverse Event
    Malfunction ·AESCULAP INC·Product code KCT·July 26, 2016

    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