BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LP-PLUS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DISPOSABLE ENDOILLUMINATOR

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

    ALINITY I CEA REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHX·May 18, 2026

    OT ULTRASMART METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 7, 2013

    XENFORM

    FDA Adverse Event
    Other ·TEI BIOSCIENCES INC.·Product code FTM·July 8, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·January 13, 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