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

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    EXTENTION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ZAVATION

    FDA UDI
    Zavation LLC·00842166190665·Polyaxial Reduction Screw 3.5x24

    Solstice Occipito-Cervico-Thoracic System

    FDA UDI
    Life Spine, Inc.·00190837022075·3.5mm SOLSTICE® Smooth Shaft Poly Screw, 24mm

    COAPT ENDOTINE CHIN 3.5 DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PVMED DDR 2430T

    FDA 510(k)
    FDA Class 2 ·Radiology

    FREESTYLE LITE

    FDA Adverse Event
    Injury ·Product code NBW·December 20, 2010

    LRG TAP PRI MOD NCK 0DEG 42MM

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

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 14, 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