BEUDAMED
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    IMX CA 15-3

    FDA 510(k)
    FDA Class 2 ·Immunology

    HCL LABORATORY SYSTEMS 200 -LISA-

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

    REFILLABLE SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DISPOSABLE FIBER OPTIC DELIVERY SYST/ND: YAG SURG

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

    SPRINT QUATTRO

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·February 15, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·January 19, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 29, 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