BEUDAMED
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    PHENCYCLIDINE EIA ASSAY

    FDA 510(k)
    FDA Unclassified ·Unknown

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100240·SILICONE TUBING FOR ASPIRATING SPECULUM

    SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION

    FDA 510(k)
    FDA Class 1 ·Microbiology

    OPTICAL FRAME

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 16, 2014

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·December 6, 2010

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·December 7, 2012

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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