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

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    CREATINE KINASE MB ENZYME IMMUNOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Precept

    FDA UDI
    Nuvasive, Inc.·00887517425997·PRECEPT Screw, 4.5x50mm Fixed

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809916495120·Long-arm Multi-Axial Cannulated Screw, Ø4.5 x 5...

    EMIT ST SERUM TRICYCLIC ANTIDEPRESSANT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    HOBBS MEDICAL/JAYCO ASPIRATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·June 19, 2014

    UNKNOWN COONRAD/MORREY HUMERAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JDC·October 19, 2010

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·December 22, 2012

    Vanguard XP Tibial Tray 67 mm Item # 195247

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020