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

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    Streamline MIS Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IUI CATHETERS

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

    ONE TOUCH ULTRASMART METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·October 6, 2008

    ULTRASONIC DISSECTOR QTY OF 6

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code LFL·June 18, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·August 5, 2011

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018