BEUDAMED
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    SURGICAL FACE MASK

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OLYMPIC MINI BILI-LITE, MODEL 77

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TABA PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    UNK - NAIL

    FDA Adverse Event
    Injury ·Product code HSB·January 9, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·November 16, 2010

    AUTOGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 1, 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