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

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    EMBRYOSCOPE AND EMBRYOSLIDE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    IQ HYDROPHILIC GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGG ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    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

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·May 3, 2013

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 5, 2008

    PUREPOINT

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQF·April 27, 2011

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022

    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