BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    SODIUM/POTASSIUM REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TOWNLEY™ Transfacetpedicular Screw Fixation System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490860543·UCS 4.0X26 X873-126 CANN LAG SCR TI

    EXPEDIUM SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arisstos™ Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRIAGE PROFILER SOB PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·June 27, 2019

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 13, 2014

    ASKU

    FDA Adverse Event
    MEDTRONIC MILACA INC.·Product code DTE·October 18, 2010

    ARMADA 14 PTA CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LIT·December 13, 2012

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014