BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ENTELLUS MEDICAL RS-SERIES SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    InMode PLUS System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    M2A 38MM MOD HD STD NK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 13, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 12, 2010

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·December 13, 2012

    Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·May 21, 2014