BEUDAMED
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    RANDOX OPIATES ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    5570 3L SYRINGE

    FDA UDI
    HANS RUDOLPH, INC.·00817136021751·5570 SERIES 3L SYR MEDISOFT

    CapSure® Spine System

    FDA UDI
    Spine Wave, Inc.·10840642105162·PS3 Screw 7.5mm x 45mm

    TEKNO-MEDICAL OBSTETRICAL FORCEPS

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

    ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BIOFINITY TORIC

    FDA Adverse Event
    Injury ·COOPERVISION MANUFACTURING, LTD.·Product code LPM·May 10, 2013

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 17, 2014

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·June 2, 2011

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018