BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HHM

    FDA UDI
    Oticon A/S·05707131260666·H110, MINIRITE 312 WL CNB HHM

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·September 15, 2020

    ZIMMER UNICOMPARTMENTAL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ZEUS ELISA HSV GC-I IGG TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BD SARS-COV-2 REAGENTS FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·September 10, 2020

    TIBIAL COMPONENT PRECOAT RIGHT MEDIAL/LEFT LATERAL SIZE 3

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HSX·February 3, 2017

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 8, 2016

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    CONSMA·Product code ITJ·May 29, 2013

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code NIQ·June 16, 2011

    PUMP MMT-508UC EA INSULIN CH EN US

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·August 22, 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