BEUDAMED
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    SILVERBACK Gorilla Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROPELLER HEAD SCREW SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304269545·

    Bernafon

    FDA UDI
    Bernafon AG·05711584079751·AQ CO7 MNR T, 2.4G NFM DPB MSIL/MAC ACCUQ

    XL Tapered Pin Reamer

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215055622·

    SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CURIEPACS (DICOM PACS SOFTWARE)

    FDA 510(k)
    FDA Class 2 ·Radiology

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN·Product code NBW·September 16, 2015

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 17, 2014

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 21, 2013

    LOCKING SCREW, FULLY THREADED 5X40 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 23, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 24, 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