BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    CERVICAL SELF-RETAINING RETRACTOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE

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

    FPC/SFPC/RFPC ACETABULAR COMPONENT

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    VASOVIEW 6 EVH SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·December 9, 2010

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code HCG·January 30, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·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