BEUDAMED
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    SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PCX 650HF RADIOGRAPHIC X-RAY

    FDA 510(k)
    FDA Class 1 ·Radiology

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 22, 2013

    QUICK FLEX LV LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC. CRMD·Product code OJX·January 15, 2014

    INSYNC MAXIMO

    FDA Adverse Event
    Malfunction ·MEDTRONIC S.A.·Product code NIK·December 14, 2010

    Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class I ·Terminated·Covidien·February 11, 2015

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015