BEUDAMED
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    Clarius Ultrasound Scanner

    FDA 510(k)
    FDA Class 2 ·Radiology

    ECHO BI-METRIC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304463233·

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583032573·ET40, KIT 312 NFM 90 L BE ENCHANT 40

    Echo® Bi-Metric® Hip System

    FDA UDI
    Biomet Orthopedics, LLC·00887868260537·

    VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010

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

    OSSTAPLE CHILL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 18, 2017

    TRANSSEPTAL NEEDLE, BRK 1, 71CM

    FDA Adverse Event
    Other ·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·July 2, 2009

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 7, 2008

    VIRTUOSO DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code LWS·August 4, 2011

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 20, 2013

    2008T HEMODIALYSIS SYS., WITH CDX

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·January 6, 2016

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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