BEUDAMED
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    T2Bacteria Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology

    REMESENSE FOR SENSITIVE TEETH

    FDA 510(k)
    FDA Class 2 ·Dental

    ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 5, 2025

    OPTIPAC 60 REFOB BONE CMT R-3

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·May 11, 2026

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·8010379 DEPUY INTL., LTD.·Product code KWA·June 17, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 22, 2011

    4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY PUERTO RICO·Product code ERL·September 18, 2008

    BIOMET BONE CMENT R 1X40 JP

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·May 22, 2025

    REFOBACIN BONE CEMENT R 1X40-3

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·June 18, 2025

    OPTIPAC 80 BIOMET BC R

    FDA Adverse Event
    Death ·BIOMET FRANCE S.A.R.L.·Product code LOD·April 9, 2026

    BIOMET BONE CEMENT R 40 -3

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·July 31, 2025

    BIOMET BONE CMENT R 1X40 JP

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·June 17, 2025

    OPTIPAC 60 REFOB BONE CMT R-3

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·February 5, 2025

    OPTIPAC 60 REFOB BONE CMT R-3

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·February 5, 2025

    BIOMET BONE CMENT R 1X40 JP

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·October 8, 2025

    BIOMET BONE CMENT R 1X40 JP

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·October 8, 2025

    BIOMET BONE CMENT R 1X40 JP

    FDA Adverse Event
    Malfunction ·BIOMET FRANCE S.A.R.L.·Product code LOD·April 8, 2025

    OPTIPAC 80 BIOMET BC R

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code LOD·February 21, 2025

    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