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

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    LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE)

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    INRATIO PT/INR TEST STRIPS

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·May 27, 2014

    LCP DRILL SLEEVE 2.7 HEAD LCP2.4 W/SCALE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code FZX·January 9, 2013

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 16, 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