BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    Synergy ODM

    FDA 510(k)
    FDA Class 2 ·Radiology

    KONIX ULTRASOUND GEL

    FDA 510(k)
    FDA Class 2 ·Radiology

    EUGENONE

    FDA 510(k)
    FDA Class 2 ·Dental

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·June 20, 2017

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·August 1, 2017

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·July 25, 2017

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·August 17, 2017

    ACCELSTIM

    FDA Adverse Event
    Injury ·ORTHOFIX·Product code LOF·June 5, 2023

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·March 21, 2017

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    GOBED II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·June 7, 2013

    SPINE SCREW AND PLUGS

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWQ·September 5, 2008

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·June 26, 2017

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019