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

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    PATIENT TROLLEY 540

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·January 9, 2013

    SUPER POLIGRIP ULTRA FRESH CREAM

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code KOL·December 2, 2010

    EDWARDS EXPANDABLE INTRODUCER SHEATH SET

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·July 18, 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