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

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    TABLE, OPERATING, FIELD 6530-00-709-8175

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MAGELLAN NEEDLE 25 G 1 INCH

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FMI·November 8, 2018

    Swoop Portable MR Imaging System

    FDA 510(k)
    FDA Class 2 ·Radiology

    INRATIO SELF-TEST

    FDA 510(k)
    FDA Class 2 ·Hematology

    MAGELLAN

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FMI·December 17, 2018

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·August 1, 2011

    SAFETY NEEDLE 25 X 1

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FMI·December 4, 2018

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·May 20, 2014

    ARTICULEZE M HEAD 36MM +8.5

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code JDI·November 7, 2012

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·UNKNOWN MANUFACTURING FACILITY·Product code KDJ·August 31, 2010

    SAFETY NEEDLE 25 X 1

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FMI·December 11, 2018

    SAFETY NEEDLE 25 X 1

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FMI·December 11, 2018

    SAFETY NEEDLE 25 G X 1"

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FMI·December 3, 2018

    SAFETY NEEDLE 25 G X 1"

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FMI·January 17, 2019

    GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000

    FDA Enforcement
    Class I ·Ongoing·Wipro GE Healthcare Private Ltd.·February 21, 2024

    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