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

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    Facilis™ Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HANDHELD PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLEXITIME FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code KWP·November 7, 2019

    ADVIA 1800

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JGS·June 26, 2013

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 27, 2011

    CUSTOM PAK

    FDA Adverse Event
    Malfunction ·ALCON HOUSTON·Product code KYG·September 26, 2008

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·August 23, 2021

    ULTRATHANE SUPRAPUBIC CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOB·August 23, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·March 17, 2022

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·August 23, 2021

    COOK COPE-LOOP CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code LJE·July 21, 2021

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018