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    Excel Medical Products, Inc.

    FDA registration
    Excel Medical Products, Inc.·5 products·🇺🇸 United States

    DA VINCI S SURGICAL SYSTEM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL,INC.·Product code NAY·September 11, 2013

    SHOCKWAVE M5+ PERIPHERAL INTRAVASCULAR LITHOTRIPSY (IVL) CATHETER

    FDA Adverse Event
    Malfunction ·SHOCKWAVE MEDICAL, INC.·Product code PPN·December 18, 2024

    SUBTALAR MBA SYSTEM

    FDA Adverse Event
    Other ·KINETIKOS MEDICAL, INC.·Product code HRS·March 18, 2004

    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

    The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, whole body (WB) and SPECT applications. The Symbia Intevo Excel integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction. The Symbia Intevo 2 integrates state-of-the-art SPECT and high quality dual slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia Intevo 6 integrates state-of-the-art SPECT and high quality six slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia Intevo 16 integrates state-of-the-art SPECT and high quality sixteen slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. Indications for use: 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 588keV. 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 place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·October 8, 2014

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·February 12, 2026

    SYMBIA EVO EXCEL

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code KPS·August 27, 2019

    ANS OCTRODE LEAD

    FDA Adverse Event
    Injury ·ADVANCED NEUROMODULATION SYSTEMS, INC·Product code GZB·January 3, 2007

    TRILOGY LONGEVITY CROSSLINKED POLY LINER, PROSTHESIS HIP

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code LPH·May 26, 2015

    FLOWTRON EXCEL / TRIO PUMPS

    FDA Adverse Event
    Injury ·GETINGE (SUZHOU) CO., LTD.·Product code KNM·August 15, 2013

    NEXGEN MOBILE FLUTED STEMMED TIBIAL PLATE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code NJL·February 3, 2015

    INFUSOMAT®

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·September 7, 2021

    TECNIS IOL

    FDA Adverse Event
    Injury ·AMO MANUFACTURING NETHERLANDS·Product code POE·August 4, 2021

    TORNADO BIOACTIVE BONE GRAFT MATRIX

    FDA Adverse Event
    Injury ·COLLAGEN MATRIX, INC.·Product code MQV·June 13, 2025

    DA VINCI S SURGICAL SYSTEM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL,INC.·Product code NAY·August 26, 2013

    MAXI MOVE

    FDA Adverse Event
    Other ·BHM MEDICAL, INC.·Product code FSA·October 4, 2011

    VERSYS HIP SYSTEM FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LZO·September 17, 2014

    DA VINCI SURGICAL SYSTEM

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL,INC.·Product code NAY·November 1, 2013

    BIA-GEN

    FDA Adverse Event
    Injury ·COLLAGEN MATRIX, INC.·Product code MQV·June 12, 2025