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

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    SOLUTION ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 7, 2010

    PFC SIG CR NPOR FEM RT SZ 4N

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·December 6, 2012

    BD PLATE CAMPYLOBACTER SB 100MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code JSJ·June 2, 2022

    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