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

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    DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP)

    FDA 510(k)
    FDA Class 2 ·Radiology

    NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·February 9, 2013

    OFFSET 30 DEGREES BROACH HANDLE - LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code GET·July 10, 2014

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·January 7, 2011

    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