BEUDAMED
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    NMI PORT II CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000

    FDA 510(k)
    FDA Class 2 ·Neurology

    HANDHELD PULSE OXIMETER MODEL M800

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

    CORAL REEF COTTON GAIT BELT STANDARD

    FDA Adverse Event
    Malfunction ·J. T. POSEY CO.·Product code IKX·May 6, 2013

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·June 16, 2011

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015