BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814206·GENUMEDI PT SILVER L III

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550124·GENUMEDI PT KNEE SUP SILVER L EW III

    PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    BMT GB KNEE STM 12X40

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code OIY·June 1, 2022

    TRANSPAC® IV W/03 ML SQUEEZE FLUSH DEVICE, 60" MACRO ADMIN SET AND PRESSURE TUBI

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·October 11, 2021

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)

    FDA Adverse Event
    Death ·ABBOTT MEDICAL·Product code NKM·December 7, 2023

    10.0MM MEDULLARY REAMER HEAD

    FDA Adverse Event
    Malfunction ·Product code HTO·October 5, 2014

    CHARGING SYSTEM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 29, 2013

    760

    FDA Adverse Event
    COVIDIEN PURITAN BENNETT·Product code CBK·June 22, 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