BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    VIDAS CMV IGM ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STARLUX PULSED LIGHT SYSTEM

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

    ASR UNI FEMORAL IMPL SIZE 41

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 29, 2013

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·December 20, 2010

    TOTAL ASR ACET IMP SIZE 54

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

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·January 4, 2022

    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