BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    PRECIMAT (R) IGA, G, M

    FDA 510(k)
    FDA Class 2 ·Immunology

    Efficia CMS200

    FDA UDI
    Philips Medical Systems Hsg·00884838058309·The Efficia CMS200 Central Monitoring System is...

    ELLEX SLIT LAMP, MODEL 30XL

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Wheelchair

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MPRI·Product code OJX·June 10, 2014

    RUBY 3

    FDA Adverse Event
    MEDTRONIC S.A.·Product code DXY·October 9, 2010

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·December 10, 2012

    Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and vital signs monitors) for multiple patients. It provides secondary operator notification of alarms from other networked medical devices. It provides for the retrospective review of alarm conditions, physiologic waves and parameters from multiple patients. The intended use of the printer, when present, is to provide hardcopy text, graphics, and wave data. The Efficia CMS200 may provide for connection and information exchange to external systems. The Efficia CMS200 is intended for use in hospitals and out of hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is administered by healthcare professionals

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·March 1, 2017

    Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and vital signs monitors) for multiple patients. It provides secondary operator notification of alarms from other networked medical devices. It provides for the retrospective review of alarm conditions, physiologic waves and parameters from multiple patients. The intended use of the printer, when present, is to provide hardcopy text, graphics, and wave data. The Efficia CMS200 may provide for connection and information exchange to external systems. The Efficia CMS200 is intended for use in hospitals and out of hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is administered by healthcare professionals

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code MHX·January 17, 2017