BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Radiology

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112687·BARRON CORNEAL PUNCH 9.25MM

    Brisbane ALIF Cage

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215018276·

    Sapphire NC Plus

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955916762·Percutaneous Transluminal Coronary Angioplasty ...

    ORTHO SUMMIT SAMPLE HANDLER

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·August 18, 1999

    NUVASIVE NEUROVISION JJB SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    AZUR PURE PERIPHERAL COIL SYSTEMS, PUSHABLE 35

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    Discovery CT 750 HD model numbers: 5232083, 5232083-2, 5232083-3, and 5232083-4. For head, whole body, cardiac and vascular X-ray Computed Tomography applications.

    FDA Recall
    Terminated ·Ge Healthcare·Product code JAK·October 1, 2009

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·November 7, 2008

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·September 1, 2011

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·July 17, 2013

    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