BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONVERTBL I.V.DUAL CHANNEL HSP

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·December 20, 2011

    CONVERTBL I.V..DUAL C

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·August 13, 2009

    PRIMARY PLUMSET PP YSITE 272CM NDEHP

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 19, 2012

    CONVERTBL I.V. DUAL C

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·October 15, 2009

    CONVERTBL I.V. DUAL CHANNEL HSP

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·July 7, 2011

    UNK

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·October 15, 2009

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 29, 2013

    UNIVERSAL DRIVER SHAFT

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·December 14, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·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