BEUDAMED
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    NIO+ Adult

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 18, 2021

    STREERABLE PTCA GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·December 26, 2024

    AGILE ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

    SSH-880CV Aplio Artida; System, Diagnostic Ultrasound

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IYO·September 28, 2010

    Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in an interventional setting.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code MQB·May 12, 2014

    MRI system: Vantage Elan, Model: MRT-2020

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code LNH·January 29, 2024

    Vantage Titan, Model: MRT-1504

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code LNH·January 29, 2024

    Aquilion One: Aquilion TSX-301B, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A multislice CT system that supports whole-body scanning.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·January 7, 2011

    Aquilion One: Aquilion TSX-301A, 64 System, X-Ray, Tomography. Toshiba American Medical Systems, Inc. A multislice CT system that supports whole-body scanning.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·January 7, 2011

    MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code LNH·January 29, 2024

    INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code OWB·March 11, 2015

    Aplio Artida Ultrasound Diagnostic System SSH-880CV. Toshiba American Medical Systems, Inc. A diagnostic ultrasound system.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IYN·October 1, 2010

    Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IYN·August 5, 2013

    Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IYN·August 5, 2013

    Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code IYN·August 5, 2013

    Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code LNH·February 21, 2012