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

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    TRANSFERRIN NEPHELOMETRIC ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYNFIX-LR SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Altus Spine Cervical Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEWPORT 2 INSTRUMENT

    FDA Adverse Event
    Other ·SEASPINE, INC.·Product code NKB·March 31, 2014

    SYMBIQ 3.13 DUAL CHA

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 2, 2012

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·July 22, 2010

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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