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

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    VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE

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

    Destiknee Total Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED) AND BLUE COLORED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 10, 2014

    HX2 TEMPERATURE MANAGEMENT SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DWC·December 5, 2012

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 22, 2015

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012