BEUDAMED
    20 results · 26ms · Sources: EU EUDAMED, US FDA

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    PATIENT EXAMINATION GLOVES (LATEX)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    JTS EXTENDEABLE IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Rejuvapen NXT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    JTS UNIT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·September 11, 2018

    JTS COIL

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·February 13, 2020

    JTS DRIVE UNIT SET

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·March 6, 2023

    GYNECARE TVT OBTURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 24, 2014

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·November 3, 2010

    UNKNOWN LEFT HIP REJUVENATE NECK

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS CORK·Product code MEH·December 19, 2012

    JTS DRIVE UNIT SET

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·March 15, 2022

    PROXIMAL TIBIA JTS (DISTAL FEMORAL COMPONENT)

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·November 28, 2018

    JTS DRIVE UNIT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·November 21, 2019

    JTS DRIVE UNIT SET

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·May 27, 2022

    JTS EXTENDIBLE DISTAL FEMORAL IMPLANT

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·July 24, 2014

    JTS DRIVE UNIT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·April 8, 2020

    JTS DRIVE UNIT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·June 29, 2020

    CUSTOM PROXIMAL FEMUR JTS REPLACEMENT IMPLANT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD.·Product code KRO·June 25, 2015

    DISTAL FEMUR JTS

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·July 18, 2019

    JTS DRIVE UNIT SET

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·April 28, 2022

    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