BEUDAMED
    7 results · 32ms · Sources: EU EUDAMED, US FDA

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    ALLIGER ULTRASONIC SURGICAL SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    12-LEAD GLOVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARMBOARD

    FDA 510(k)
    FDA Class 2 ·Radiology

    CE INTERMATE LV 50, 24 PACK, 50126

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·December 20, 2010

    5MM, 45CM PEEK MULTI-FUNCTION HANDLE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·July 15, 2014

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·December 21, 2012

    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