BEUDAMED
    11 results · 29ms · Sources: EU EUDAMED, US FDA

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    FUTREX-5000A

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    24M - Par Electric West Class A FA/Burn

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588226019·24M - Par Electric West Class A FA/Burn

    DILUENT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GIF·December 4, 2006

    POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FilmArray Pneumonia Panel plus

    FDA 510(k)
    FDA Class 2 ·Pathology

    Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, List Numbers: 99226-01, 08H17-01,(on box), 99226-01, 08H17-02 (on bottle); Product is distributed by Abbott Hematology, 5440 Patrick Henry Dr., Santa Clara, CA 95054

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GKZ·September 20, 2005

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·January 18, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 14, 2014

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION·Product code HAW·November 19, 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

    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020