BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    DePuy Corail AMT Hip Prosthesis

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111164033·VORSE TUBE OCC FCP W/GD SER 6"

    CoaguChek Vantus System

    FDA 510(k)
    FDA Class 2 ·Hematology

    LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 15, 2014

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 24, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 17, 2013

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017