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

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    DUALYSE-CATH - CODES #1132.212, 1132.112

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ULTIMA LITE

    FDA 510(k)
    FDA Class 2 ·Dental

    VINYL EXAM GLOVES (MFG. JM GLOVES CO. LTD.)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TENDRIL SDX

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010

    GENESYS HTA PROCERVA®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code MNB·January 4, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 16, 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