BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    DIGITAL DOC

    FDA 510(k)
    FDA Class 1 ·Dental

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981663·anteriors; shade D3 light; mould BIS2

    HEARING AID, ITE MODULAR MODEL I, II, V

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ENDURANT ABDOMINAL STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·February 27, 2013

    SURGISTOOL

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIVISION·Product code FZM·January 12, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 5, 2014

    CONNECTOR, 1/4" X 1/4" STRAIGHT WITH LUER LOCK PORT

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA·Product code OEZ·April 26, 2016

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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