BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    Neuro-IOM system with Neuro-IOM.NET software

    FDA 510(k)
    FDA Class 2 ·Neurology

    STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS

    FDA 510(k)
    FDA Class 2 ·Radiology

    POLY-CHEM 90 GLUCOSE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 12, 2024

    CARDINALHEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 13, 2024

    CARDINALHEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 13, 2024

    CARDINALHEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 13, 2024

    CARDINALHEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 13, 2024

    DHS/DCS COUPLING SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code HWC·October 6, 2008

    IAB: 8 FR - 30 CC FOS

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·June 24, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    BD INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

    CARDINALHEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code PNR·April 13, 2024

    S8 PREMIUM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·April 20, 2020

    5.5 EXP VERSE DI SET SCR

    FDA Adverse Event
    Malfunction ·DEPUY SPINE INC·Product code NKB·September 21, 2021

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014