BEUDAMED
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    S-Plant Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    RELIANCE CERVICAL IBF SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·June 14, 2024

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·July 22, 2024

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·January 10, 2025

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008

    ACCUDATA ® GTS PLUS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CGA·September 1, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·July 17, 2013

    NUVASIVE RELINE SYSTEM

    FDA Adverse Event
    Injury ·NUVASIVE, INCORPORATED·Product code NKB·September 2, 2022

    NUVASIVE RELINE SYSTEM

    FDA Adverse Event
    Injury ·NUVASIVE, INCORPORATED·Product code NKB·September 2, 2022

    NUVASIVE RELINE SYSTEM

    FDA Adverse Event
    Injury ·NUVASIVE, INCORPORATED·Product code NKB·September 2, 2022

    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