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

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    HCL LABORATORY SYSTEMS 200 -LISA-

    FDA Adverse Event
    Other ·HYCEL DIAGNOSTICS·Product code JJF·November 8, 2000

    HCL - 200 BIOCHEMISTRY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER

    FDA 510(k)
    FDA Class 2 ·Neurology

    IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MAXIMO VR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·February 15, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 29, 2014

    INTEGRATED APD SET W/CASSETTE3-PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 19, 2011

    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