BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    RSH BILIARY STONE REMOVAL DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PERIMETER INTERBODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ONCO TRAC MODEL 1, 2, 4

    FDA 510(k)
    FDA Class 2 ·Radiology

    POSEY BED

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

    CARELINK

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

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014

    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