BEUDAMED
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    Control-IQ Technology

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113400·IMPLANT KNIFE 4.0MM (BX/5)

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102756·DODICK-KAMMANN CHOPPER STRAIGHT 1.5MM

    FilmArray Global Fever Panel External Control Kit

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 6, 2014

    GENESYS HTA PROCERVA PROCEDURE SET

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code MNB·June 12, 2013

    UNKNOWN SCREW

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HWC·August 26, 2011

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US

    FDA Adverse Event
    Injury ·TERUMO MEDICAL CORPORATION·Product code MGB·September 20, 2021

    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