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

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    ASSURE SELF SEALING STERILIZATION POUCH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Ventura NanoMetalene System

    FDA UDI
    Seaspine Orthopedics Corporation·10889981151850·Ventura NM Trial, 9mm x 24mm x 12mm, Lordotic

    COLLAGEN DENTAL WOUND DRESSINGS

    FDA 510(k)
    FDA Class 2 ·Dental

    WOUND DRESSING WITH MANUKA HONEY

    FDA 510(k)
    FDA Unclassified ·Unknown

    FREESTYLE LITE

    FDA Adverse Event
    Injury ·Product code NBW·October 8, 2010

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·January 29, 2013

    TALENT CAPTIVIA STENT GRAFT SYS

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·December 16, 2010

    ENDEAVOR SPRINT RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·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