BEUDAMED
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    Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 2, 2020

    Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 2, 2020

    Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 15, 2019

    Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 2, 2020

    Cios Alpha, mobile X-ray system

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 6, 2016

    Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 8, 2015

    Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 20, 2020

    Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 20, 2020

    Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 3, 2020

    Siemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 20, 2020

    CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 6, 2016

    Cios care fusion system

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 17, 2019

    Cios Alpha VA20/ VA30 mobile X-Ray systems

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 17, 2019

    CIOS ALPHA; image intensified fluoroscopic x-ray system

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·November 4, 2015

    Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 3, 2020

    Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 15, 2019

    Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·January 15, 2020

    THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.

    FDA Enforcement
    Class II ·Terminated·Bios S.r.l.·November 8, 2017

    ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·October 15, 2014

    The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.

    FDA Enforcement
    Class II ·Terminated·Bio-Rad Laboratories·September 26, 2012