BEUDAMED
    39 results · 51ms · Sources: EU EUDAMED, US FDA

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    TECNIS IOL

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·April 30, 2025

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Enforcement
    Class II ·Terminated·Optovue Inc.·October 31, 2012

    OPTICAL INTEGRITY GENERAL SHAPED FIBER

    FDA Adverse Event
    OPTICAL INTERGRITY INC.·Product code GEX·March 15, 2012

    TECNIS IOL

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·May 2, 2025

    CATALYS SYSTEM

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code OOE·May 17, 2024

    INTRALASE FS2

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code GEX·September 20, 2024

    CATALYS SYSTEM

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC·Product code OOE·October 2, 2018

    MOSAIQ System; customers with Siemens branded linear accelerators with a COHERENCE RT Therapist workspace version 2.1a and the 3rd party MOSAIQ Oncology Information System. MOSAIQ Oncology information system is owned and marketed by IMPAC Medical System, Inc. MOSAIQ is distributed by Siemens Medical Solutions USA, Inc, Radiation Oncology under a distributor contract with IMPAC Medical. Distributed by Siemens Healthcare, Concord, Ca. Product Usage: Medical charged particle radiation therapy system. The intended use of the SIEMENS branded PRIMUS, ONCOR and ARTISTE Solution family of linear accelerators systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. P

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·February 14, 2012

    MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DRF·December 31, 2025

    CATALYS SYSTEM

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·February 12, 2019

    NONE

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code GCJ·July 13, 2023

    DAVINCI X

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·November 11, 2025

    CATALYS SYSTEM

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·October 13, 2020

    CATALYS SYSTEM

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·October 13, 2020

    LIQUID OPTICS INTERFACE

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·July 25, 2024

    WHITESTAR SIGNATURE

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code HQC·August 3, 2023

    WHITESTAR SIGNATURE

    FDA Adverse Event
    Injury ·AMO MANUFACTURING USA, LLC·Product code HQC·August 3, 2023

    LENSX LASER SYSTEM

    FDA Adverse Event
    Injury ·ALCON LENSX, INC.·Product code OOE·September 7, 2015

    NONE

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code GCJ·October 6, 2025

    ION

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code EOQ·May 4, 2026