BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    INTRASITE HYDROCOLLOID DRESSING (REVISED LABELING)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083017132·STR, 4 electrode, MPD-S-L, 2mm electrode spacing

    XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INFUSION IV SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·June 30, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 17, 2010

    TOTALCARE SPORT

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·November 21, 2012

    ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Injury ·COOK INC·Product code DQX·January 26, 2018

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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