BEUDAMED
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    ACUSON ACUNAV 8F-90 ULTRASOUND CATHETER

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code OBJ·December 1, 2017

    ACUSON ACUNAV 8F-90 ULTRASOUND CATHETER

    FDA Adverse Event
    Injury ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code OBJ·December 1, 2017

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIR·September 27, 2023

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIR·May 26, 2023

    VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·July 3, 2013

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code QZK·October 29, 2025

    GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·September 12, 2025

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIR·April 25, 2025

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIR·April 25, 2025

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code PRL·December 17, 2025

    Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 24, 2013

    GORE® VIATORR® TIPS ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIR·December 9, 2025

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code QZK·December 22, 2025

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIR·October 8, 2024

    Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications. trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·February 12, 2013

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIR·May 10, 2024

    GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIR·October 23, 2023

    GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code QZK·March 13, 2026

    GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    FDA Adverse Event
    Malfunction ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·August 5, 2024

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·W. L. GORE & ASSOCIATES, INC.·Product code PRL·October 29, 2025