BEUDAMED
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    BELLYBOARD, SBRT ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Radiology

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657066846·Laparoscopic Spatula with Irrigation, 5mm X 45cm

    SafeGuide® Single

    FDA UDI
    DIVERSATEK HEALTHCARE, INC.·00816734023280·Disposable Over the Guidewire Esophageal Dilato...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694045445·PrimaLIF LLIF PEEK Implant, 15mm X 18mm X 45mm,...

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172970386·

    GENESIS IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM

    FDA 510(k)
    FDA Class 2 ·Immunology

    MECTALIF ANT - LAG

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVD·April 12, 2024

    IDENTITY SR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code LWP·January 13, 2014

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 21, 2013

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·May 6, 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