BEUDAMED
    72 results · 70ms · Sources: EU EUDAMED, US FDA

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    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS·Product code LWS·August 8, 2000

    NONE

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code GCJ·July 3, 2023

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWP·April 16, 2018

    PULSESELECT

    FDA Adverse Event
    Malfunction ·MEDTRONIC CRYOCATH LP·Product code QZI·May 2, 2025

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·December 9, 2025

    PASSPORT LOW PROFILE GASTROSTOMY DEVICE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code KNT·August 23, 2019

    ENDOWRIST

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·February 20, 2023

    DAVINCI XI

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·February 15, 2023

    NEXGEN PROLONG ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 23, 2015

    Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis applications via QLAB integration and provide integrated tools that allow users to manually assess and score cardiac wall motion and export images and / or exams and reports. Q-Station can view DICOM images of non-ultrasound images such as CT, MR, NM, CR, MG, XA, PET, RT and X-Ray modalities for reference viewing. It support connectivity to ultrasound systems, PACS and other DICOM storage repositories.

    FDA Enforcement
    Class II ·Terminated·Philips Ultrasound, Inc.·June 24, 2015

    NONE

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·September 19, 2025

    INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC·Product code PKL·June 10, 2024

    Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis applications via QLAB integration and provide integrated tools that allow users to manually assess and score cardiac wall motion and export images and / or exams and reports. Q-Station can view DICOM images of non-ultrasound images such as CT, MR, NM, CR, MG, XA, PET, RT and X-Ray modalities for reference viewing. It support connectivity to ultrasound systems, PACS and other DICOM storage repositories.

    FDA Recall
    Terminated ·Philips Ultrasound, Inc.·Product code LLZ·May 15, 2015

    CAPTURA SERRATED LARGE FORCEP-SPIKE

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL INC.·Product code FCL·August 21, 2014

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F

    FDA Adverse Event
    Malfunction ·CORDIS SANTA CLARA·Product code MGB·October 2, 2017

    MYNXGRIP VASCULAR CLOSURE DEVICE 5F

    FDA Adverse Event
    Malfunction ·CORDIS SANTA CLARA·Product code MGB·October 2, 2017

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code NKM·December 7, 2021

    MITRACLIP G4 CLIP DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code NKM·December 7, 2021

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F

    FDA Adverse Event
    Malfunction ·CORDIS SANTA CLARA·Product code MGB·September 27, 2017

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F-7F

    FDA Adverse Event
    Malfunction ·CORDIS SANTA CLARA·Product code MGB·September 27, 2017