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

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    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code ONU·January 31, 2019

    PACIFIC XTREME

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO·Product code LIT·January 31, 2019

    PACIFIC PLUS

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO·Product code LIT·January 31, 2019

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code ONU·January 31, 2019

    PACIFIC PLUS

    FDA Adverse Event
    Death ·MEDTRONIC MEXICO·Product code LIT·January 31, 2019

    PACIFIC XTREME

    FDA Adverse Event
    Death ·MEDTRONIC MEXICO·Product code LIT·January 31, 2019

    SENSAR IOL

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·May 9, 2025

    FS DISPOSABLE INTERFACE

    FDA Adverse Event
    Malfunction ·AMO MANUFACTURING USA, LLC·Product code GEX·November 22, 2021

    ELLIPS FX PHACO HANDPIECE

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQC·December 2, 2024

    UNK_PHACO TIP/NEEDLE

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code HQC·December 2, 2024

    TECNIS SIMPLICITY

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·September 4, 2024

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYF·September 15, 2020

    BAERVELDT SHUNT

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYF·September 15, 2020

    HEALON

    FDA Adverse Event
    Injury ·AMO UPPSALA AB·Product code LZP·December 4, 2021

    TECNIS IOL

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·February 27, 2023

    TECNIS IOL

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code MJP·February 28, 2023

    TECNIS 1 MULTIFOCAL

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code MFK·August 26, 2019

    SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LTI·May 7, 2025

    UNK_MULTIFOCAL IOL

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code MFK·December 17, 2021

    TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system.

    FDA Recall
    Open, Classified ·Echopixel, Inc.·Product code LLZ·April 11, 2016