BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    OLYMPUS CREATINE KINASE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 28, 2024

    MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SURGICAL APPAREL

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

    GOBED+

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·January 22, 2013

    SYNCHROMED

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·December 7, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 5, 2014

    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