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

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    C-MAX+ (PLUS)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BIOSPINE VBR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VADI MANUAL RESUSCITATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015

    GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM

    FDA Adverse Event
    Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 24, 2013

    VIRTUOSO II DR

    FDA Adverse Event
    Death ·MEDTRONIC S.A.·Product code LWS·June 16, 2011

    ACUVUE OASYS WITH HYDRACLEAR

    FDA Adverse Event
    Injury ·VISTAKON·Product code LPL·August 20, 2008

    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