BEUDAMED
    16 results · 27ms · Sources: EU EUDAMED, US FDA

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    Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304271807·

    ZenFlex CM

    FDA UDI
    Kerr Corporation·00195062145629·.15/.06/31mm ZenFlex CM NiTi FILE REFILL PACK

    Vanguard Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304473072·

    SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ARTISTE SOLUTION WITH SYS_VB50 UPDATE

    FDA 510(k)
    FDA Class 2 ·Radiology

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    I-STAT EC4+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 4, 2008

    HOLLOW-REAMER-COMPL ANTICLOCKWISE CUTTIN

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTO·June 22, 2013

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 8, 2011

    SYNGO SUITE FOR ONCOLOGY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012

    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