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

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    Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EEVA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Simplexa COVID-19 Direct

    FDA 510(k)
    FDA Class 2 ·Microbiology

    THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·November 11, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2013

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·February 5, 2018

    AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015