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

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    BIOTIS HAEMOPHILUS IDENTIFICATION QUAD

    FDA 510(k)
    FDA Class 1 ·Microbiology

    U-IGNITE Bladeless Trocar

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

    SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FRESENIUS DIALYZER

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·April 23, 2014

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 10, 2012

    SENSOR ENLITE

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OZO·June 23, 2015

    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