BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    CATALOG NO. J-ACT+ & QC-ACT+

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOCHRON SIGNATURE ELITE

    FDA Adverse Event
    Malfunction ·ACCRIVA DIAGNOSTICS·Product code JPA·May 25, 2016

    Forceps

    FDA UDI
    KOROS U.S.A., INC.·10840199539816·DeBakey-Diethrich Coronary Artery Forceps 20cm ...

    MILLENIUM, MODELS 2000, 2001 AND 2002

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EQUINOXE HUMERAL HEAD, SHORT

    FDA Adverse Event
    Malfunction ·EXACTECH, INC.·Product code KWS·April 23, 2014

    ORTHOPEDIATRICS PEDILOC BONE SCREW

    FDA Adverse Event
    Malfunction ·ORTHOPEDIATRICS CORP·Product code HRS·January 30, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS INNOVATION CENTER - SILICON VALLEY·Product code GEX·December 22, 2010

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Enforcement
    Class II ·Ongoing·Osteomed, LLC·December 15, 2021

    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