BEUDAMED
    22 results · 29ms · Sources: EU EUDAMED, US FDA

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    SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·March 1, 2024

    VYGON LATEX FREE BIONECTOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)

    FDA 510(k)
    FDA Class 2 ·Neurology

    SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·June 4, 2019

    VERTE-STACK® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code MQP·October 8, 2014

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 8, 2013

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·June 28, 2011

    SHIDEN

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 10, 2020

    DIVA

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

    DIVA

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·June 28, 2017

    SHIDEN HP

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·April 18, 2022

    SHIDEN

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·September 2, 2021

    SHIDEN

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·January 6, 2022

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·March 28, 2017

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·January 26, 2017

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·April 13, 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