BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    EVEREST SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COCOON HYGIENIST

    FDA 510(k)
    FDA Class 1 ·Dental

    ENDOFLIP GASTRIC TUBE

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

    SIZE #4 4-IN-1 CUTTING BLOCK CAPTURED ASSY. TRIA. EXP. INSTR.

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 31, 2013

    LARYNG-O-JET KIT 4%

    FDA Adverse Event
    Injury ·INTERNATIONAL MEDICATION SYSTEMS, LIMITED·Product code FMF·June 21, 2011

    COAGUCHEK XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·August 28, 2008

    TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016