BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    AMPLIFIER MODEL N3B-EEG

    FDA 510(k)
    FDA Class 2 ·Neurology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293920·

    BOTTLE, BLOOD CULTURE, BI-PHASIC

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SEQUENTIAL PRESSURE CUFF

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ENDEAVOR SPRINT RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·October 4, 2012

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·May 13, 2015

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 27, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024