BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    OSTEONICS MICROSUTERED FEMORAL COMPONENTES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VITAL-PORT M.R.I. DUAL LUMEN VASCULAR ACCESS SYST.

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TITANIUM ALLOY SONGER CABLE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DQO·January 14, 2013

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 10, 2010

    QUICKSITE LV

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 10, 2014

    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