BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    CHOCOLATE AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PROFEMUR S HIP STEM

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    OWL CANNULAE

    FDA 510(k)
    FDA Class 2 ·Neurology

    TFNA SCREW 90MM - STERILE

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HSB·March 28, 2017

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·May 30, 2014

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·October 24, 2012

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·September 17, 2010

    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