BEUDAMED
    8 results · 22ms · Sources: EU EUDAMED, US FDA

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    BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 21, 2014

    IDESIGN AWS SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HKO·June 26, 2013

    ZIMMER PULSAVAC PLUS FAN SPRAY KIT

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code FQH·June 16, 2011

    PIPELINE FLEX

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·July 21, 2022

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018