BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    CHOCOLATE AGAR

    FDA 510(k)
    FDA Class 1 ·Microbiology

    B LOCUS HIGH RES SSP UNITRAY KIT WITH TAQ POLY

    FDA Adverse Event
    Malfunction ·LIFE TECHNOLOGIES CORP.·Product code MZI·January 15, 2014

    ORAPIK PERIODONTAL SCALER

    FDA 510(k)
    FDA Class 1 ·Dental

    NEEDLE W/STYLET FOR IMPLANTATION

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·June 10, 2014

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·October 11, 2010

    EXOSEAL VASCULAR CLOSURE DEVICE (VCD)

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code MGB·December 10, 2012

    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