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

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    REUSABLE FIBEROPTIC LIGHTPIPE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    VENTILATOR, INFANT MODEL 100

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    InVivo Web Viewer

    FDA 510(k)
    FDA Class 2 ·Radiology

    COOK SPECTRUM

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·December 27, 2018

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 18, 2014

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code FOZ·October 20, 2010

    ALTRX +4 NEUT 40IDX56OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·December 20, 2012

    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