BEUDAMED
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    BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040067635·MOLAR BAND LR 2ND 33.5 (2)

    BioPassive®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70611391·BioQuick LP Brackets .022" Easyquick Base 20 Br...

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code GWF·October 4, 2013

    LORENZ LACTOSORB PANELS AND FASTENERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code GWF·February 20, 2018

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code GWF·December 2, 2013

    NIM-ECLIPSE® PATIENT MODULE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·December 6, 2017

    PROBE SPK1004 SURGEON CONTROLLED

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED, INC.·Product code ETN·May 17, 2013

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·December 14, 2015

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014

    COMPUTER NOTEBOOK (INTERNATIONAL

    FDA Adverse Event
    Malfunction ·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·May 9, 2026

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·April 16, 2013

    CE INTERMATE LV 100, 24 PACK,50126

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·April 18, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS CORP.·Product code LFR·June 13, 2008

    CONTROLLER ECLC ECLIPSE

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·May 23, 2014

    NIM-ECLIPSE PREAMPLIFIER

    FDA Adverse Event
    Malfunction ·MEDTRONIC XOMED INC.·Product code GWF·July 7, 2021

    COMPUTER NOTEBOOK (INTERNATIONAL)

    FDA Adverse Event
    Malfunction ·MEDTRONIC (CHANGZHOU) MEDICAL DEVICES·Product code GWF·April 13, 2026

    Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·May 29, 2013