BEUDAMED
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    UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System

    FDA 510(k)
    FDA Class 2 ·Hematology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776080372·Frazier Suction Tube,

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704399493·FERGUSON FRAZIER SUCTION TUBE 10 FRENCH SIZE 4

    ECHO HIP SYSTEM INSTRUMENTATION

    FDA UDI
    Biomet Orthopedics, LLC·00880304467545·

    Echo® Hip System Instrumentation

    FDA UDI
    Biomet Orthopedics, LLC·00887868474583·

    VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 22, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 22, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 3, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 27, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 12, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·May 13, 2026

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·June 6, 2013

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 14, 2011

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·September 9, 2008

    ANATOMIC

    FDA Adverse Event
    Malfunction ·AMPLITUDE·Product code JWH·December 11, 2018

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 11, 2025

    ANGIODYNAMICS / SMART PORT

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code LJT·August 21, 2017

    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