BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    FOUNDATION POSTERIOR STABILIZED KNEE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Portrait CSSXB

    FDA UDI
    GE Medical Systems Information Technologies, Inc.·00195278659446·PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1...

    TOTAL ACROSS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·January 29, 2013

    MD - HARDWARE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·December 20, 2010

    LARGE MOD HEAD ADAPT 12/14 +5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·July 15, 2014

    OTC Pregnancy Tests. Name: Sure Check hCG Cassette Pregnancy Test. --- Description: the Sure Check hCG Cassette Pregnancy test consists of a lateral flow membrane pad containing anti- hCG monoclonal antibody conjugated to colloidal gold contained in a plastic cassette. It differs from the Sure Check Midstream product in that the lateral flow membrane pad is placed in a cassette and the urine sample is added by pipette rather than by urinating on the absorbent wick. The device is packaged in a foil pouch with desiccant. This product is shipped as bulk packaged product of varying quantities (Catalog # PT127-OTC ordered by Innovative Chemical Co., and Pruebas Moderna Del Istmo; Catalog # PT210 ordered by LABSCO). --- 510(k) K933529/A.

    FDA Recall
    Terminated ·Chembio Diagnostic System Inc·Product code LCX·October 6, 2004