BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    TYPE 1 & 2 (HUMIDAIR I & II)

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    ELITE ELECTROMED L.I.T.E. 4/1

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee

    FDA 510(k)
    FDA Class 2 ·Neurology

    APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JDO·November 13, 2014

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·November 13, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code NVY·February 9, 2013

    2124215-2010-23838

    FDA Adverse Event
    Injury ·GUIDANT PUERTO RICO BV·Product code NVN·January 10, 2011

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 23, 2014

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017