BEUDAMED
    214 results · 93ms · Sources: EU EUDAMED, US FDA

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    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·July 13, 2015

    EXCEL T-HANDLE

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code LXH·August 2, 2018

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DYE·June 16, 2009

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·January 3, 2019

    LIKORALL OVERHEAD LIFT

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FSA·February 26, 2026

    RESTORE ADVANCED

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·February 20, 2012

    CAPSURE SENSE

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 13, 2010

    CAPSURE SENSE

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 13, 2010

    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

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 4, 2012

    EXCEL BLOOD GLUCOSE STRIPS

    FDA Adverse Event
    Malfunction ·*·Product code CFR·October 19, 2001

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·November 5, 2012

    ALGOVITA SPINAL CORD STIMULATION

    FDA Adverse Event
    Injury ·NUVECTRA·Product code LGW·July 28, 2016

    VIKING M

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FSA·February 19, 2026

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 3, 2014

    ASSY,HANDPIECE,40KHZ

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PXR·February 5, 2021

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code EZW·August 13, 2015

    INTELLIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·September 25, 2019

    CLAREON VIVITY EXTENDED VISION UV ABSORBING IOL W/AUTONOME DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·ALCON LABORATORIES IRELAND LTD.·Product code POE·February 27, 2026

    ACRYSOF IQ PANOPTIX UV ABSORBING TRIFOCAL IOL

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LLC - HUNTINGTON·Product code MFK·March 10, 2023