BEUDAMED
    7 results · 23ms · Sources: EU EUDAMED, US FDA

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    EZ LDL CHOLESTEROL TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES

    FDA 510(k)
    FDA Class 2 ·Microbiology

    RECEPTAL (R) SAF-GARD(TM) SUCTION LINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 7, 2013

    ACCU-CHEK D-TRONPLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·January 26, 2011

    XENFORM

    FDA Adverse Event
    Other ·TEI BIOSCIENCES INC.·Product code FTM·July 8, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021