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

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    BILIRUBIN ASSAY KIT DIRECT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Xario 200, V3.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    POWER LOC

    FDA Adverse Event
    Malfunction ·BARD·Product code FOZ·May 27, 2014

    EXTENSION SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·November 21, 2012

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2015

    VITROS Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS Chemistry Systems typically used in hospital laboratories. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CHI·October 9, 2006