BEUDAMED
    55 results · 69ms · Sources: EU EUDAMED, US FDA

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    TRITON SPONGE

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP·Product code PBZ·April 27, 2023

    INVISALIGN

    FDA Adverse Event
    Other ·ALIGN TECHNOLOGY, INC.·Product code NXC·March 13, 2012

    CT EXPRES

    FDA Adverse Event
    Injury ·BRACCO INJENEERING S.A.·Product code IZQ·April 21, 2026

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Injury ·COOK INC·Product code MIH·January 30, 2018

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MIH·May 21, 2020

    BD CATHENA¿ SAFETY IV CATHETER WITH WINGS AND BD MULTIGUARD¿ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·April 18, 2023

    P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.

    FDA Enforcement
    Class II ·Terminated·SonoSite, Inc.·October 23, 2013

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·June 4, 2019

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    FDA Adverse Event
    Injury ·COOK INC·Product code MIH·September 8, 2016

    ALTRAZEAL TRANSFORMING POWDER DRESSING WITH NANOFLEX

    FDA Adverse Event
    Malfunction ·ULURU INC, APLUS SECURE PACKAGING·Product code NAE·November 15, 2012

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DRF·March 19, 2025

    OPD-SCAN III

    FDA Adverse Event
    Injury ·NIDEK CO. LTD.·Product code HKO·August 17, 2018

    SPY FLUORESCENCE IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·NOVADAQ TECHNOLOGIES INC.·Product code IZI·February 3, 2017

    VISUALASE

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC·Product code GEX·December 18, 2020

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·June 14, 2024

    The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization. The Symbia Intevo Series are xSPECT systems. These are SPECT and T systems integrated through xSPECT technology during image registration and reconstruction. This xSPECT integration enables the use of extra-modal information for high image quality and quantification. The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 5S8keV. CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy. Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·January 14, 2015

    TECNIS IOL

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code MJP·December 22, 2022

    Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system employs Toshibas innovative dose-reduction technologies and a fast reconstruction unit designed to minimize the patient exposure dose and improve the workflow. The wide range of advanced applications is designed for operators of all levels of experience, maximizing performance. This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Lightning has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·May 4, 2016

    ION

    FDA Adverse Event
    Death ·INTUITIVE SURGICAL, INC·Product code EOQ·October 1, 2020

    EC-5000CXIII

    FDA Adverse Event
    Malfunction ·NIDEK INCORPORATED·Product code HQF·November 7, 2016