BEUDAMED
    19 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·November 27, 2013

    Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014

    ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 17, 2013

    SOMATOM Confidence with software syngo.CT VB20 Model #10590100

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

    Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for delivery of contrast media and saline during MR applications. It is intended to be used for the specific purpose of injecting intravenous MR contrast media and saline into the human vascular system for diagnostic studies in magnetic resonance imaging (MRI) applications with MRI scanners that have a magnetic field strength between 0.7 and 3.0 Tesla. Only trained healthcare professionals are intended to operate this device.

    FDA Enforcement
    Class II ·Terminated·Bayer Healthcare·July 27, 2016

    Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 24, 2015

    Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament, non-absorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·April 2, 2014

    Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Silky II Polydek White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable surgical Suture, USP, Sterile, Deknatel; Silky II Polydek, Green Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Polylene Green Braided Polyester Suture Nonabsorbable surgical Suture, USP, Deknatel; Bard FIXT Braided Polyester, Green PTFE Rx Only, Teleflex Research Triangle Park, NC USA, Assembled in Mexico. Indicated for use in soft tissue approximation.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·May 14, 2014

    Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016

    Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·June 13, 2018

    Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

    Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals. Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information. Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies. Contraindications: Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·July 3, 2019

    Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

    Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·October 7, 2020

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Ingenuity Flex, and the MX8000 Dual v. EXP scanners)

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 11, 2014

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012