BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    INTERBODY CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·May 29, 2013

    MAVERICK2 BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·June 20, 2011

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE·Product code FDF·July 22, 2016

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD.·Product code FCX·July 22, 2016

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE·Product code FDS·July 22, 2016

    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