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

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    SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    SUNMARK OVER-DOOR HEAD TRACTION SET

    FDA Adverse Event
    Injury ·SUNMARK HOME HEALTH CARE CO MCKESSON CORP·Product code HST·October 16, 2001

    Surgical Navigation Advanced Platform (SNAP)

    FDA 510(k)
    FDA Class 2 ·Radiology

    NC-STAT

    FDA 510(k)
    FDA Class 2 ·Neurology

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·December 5, 2012

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 22, 2015

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012