BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    MODEL 10200 PREMATURE INFANT INCUBATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Navigated Instrument System

    FDA 510(k)
    FDA Class 2 ·Neurology

    ICLH TIBIAL PLATEAU

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYMBIQ DUAL CHANNEL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 20, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 9, 2010

    ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·December 10, 2012

    EV3 Pipeline Flex Embolization Device with Flex Shield Technology

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    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