BEUDAMED
    37 results · 74ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement ×

    Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·March 27, 2019

    ASPIRE Cristalle (for FDR-3000AWS) The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·February 28, 2018

    Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·February 28, 2018

    Aspire HD Plus, Aspire HD-s (for FDR-2000AWS) The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire ND-s (FDR MS-2000), generate full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·February 28, 2018

    Fuji Computed Radiography Mammography Suite, FCRMS (for CR-IR363AWS) The Fuji Computed Radiography Mammography Suite (FCRMS) is a software device that, in conjunction with a specified Fuji Computed Radiography system forms the Fuji Computed Radiography for mammography (FCRm) device. FCRm with a dedicated mammographic x-ray machine generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic (SFM) systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·February 28, 2018

    Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·June 9, 2021

    Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·July 19, 2017

    Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·September 23, 2015

    Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma.

    FDA Enforcement
    Class III ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·February 3, 2021

    Smart CR Digital Computed Radiography System; Model Number: CR-IR346RU

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·May 11, 2016

    FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·February 3, 2021

    Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·May 20, 2015

    Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·December 23, 2015

    Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000. A mammography system used for screening and diagnosis of breast cancer.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·May 13, 2015

    Endoscope ED-450XL5 Operation Manual: Cleaning, Disinfection and Storage

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·June 8, 2016

    Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·June 8, 2016

    Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·September 30, 2015

    FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·October 4, 2017

    Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. Also intended for installation on an off-the-shelf PC networked with Fuji Synapse PACS.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·June 29, 2016

    ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.

    FDA Enforcement
    Class II ·Terminated·Fujifilm Medical Systems U.S.A., Inc.·January 24, 2018