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

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    Portex Uncuffed Oral/Nasal Tracheal Tubes, Murphy Eye Siliconised 5 mm x 25cm Reference Number: 100/141/050

    FDA Recall
    Terminated ·Portex Ltd. Reachfields Boundry Road Hythe, Kent United Kingdom·May 16, 2003

    Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 2.5 mm Product Code: 100/141/025. Intended for oral and/or nasal intubation for airway management.

    FDA Recall
    Terminated ·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009

    Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 3.5 mm Product Code: 100/141/035. Intended for oral and/or nasal intubation for airway management.

    FDA Recall
    Terminated ·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009

    Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 3.0 mm Product Code: 100/141/030. Intended for oral and/or nasal intubation for airway management.

    FDA Recall
    Terminated ·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009

    Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

    FDA Enforcement
    Class I ·Terminated·Ventlab Corporation·November 7, 2012

    Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,

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

    Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.

    FDA Enforcement
    Class II ·Terminated·Bayer Healthcare·September 23, 2015

    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

    Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    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

    Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography Systems that are 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·July 25, 2012

    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

    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015

    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