BEUDAMED
    15 results · 35ms · Sources: EU EUDAMED, US FDA

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    REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207

    FDA 510(k)
    FDA Class 2 ·Hematology

    XPS® HANDPIECE - VISAO®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·December 9, 2015

    XPS® HANDPIECE - VISAO®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·January 8, 2016

    DENSICHECK PLUS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Daytona® Small Stature Growth Rod Conversion Set

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XPS HANDPIECE - VISAO

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·November 2, 2021

    DRILL 3334800 VISAO 80K HANDPIECE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC.·Product code ERL·July 2, 2013

    XPS® HANDPIECE - VISAO®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017

    XPS® HANDPIECE - VISAO®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ERL·December 1, 2017

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 25, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 2, 2013

    COMPANION 1000

    FDA Adverse Event
    Injury ·CAIRE, INC.·Product code BYJ·November 1, 2010

    XPS® HANDPIECE - VISAO®

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code ERL·June 9, 2016

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

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