BEUDAMED
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    ABBOTT STREP A CONTROLS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    KULAVAC

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

    KSEA MEDI PACK

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

     AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 26, 2024

    ALLURA XPER FD10

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code IZI·June 2, 2014

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·January 11, 2013

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 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