BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    KLENZYME

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Bioseal Inc.

    FDA UDI
    BIOSEAL·00630094194493·Button White 1 1/8"

    EMIT AMITRIPTYLINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MANUAL AND MOTORIZED FLEXION DISTRACTION TABLES

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    UNKNOWN DISCOVER ARTIFICIAL DISC

    FDA Adverse Event
    Injury ·DEPUY SYNTHES SPINE·Product code MJO·May 15, 2017

    SPECTRAFLEX

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code DTB·February 6, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 3, 2011

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE·Product code KDJ·July 18, 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