BEUDAMED
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    STORM MINI SCREW

    FDA 510(k)
    FDA Class 2 ·Dental

    All Flow Valved Insp. Mthpc

    FDA UDI
    ALLIANCE TECH MEDICAL INC·00384620000757·

    ArgenZ HT+ 98x20 D4

    FDA UDI
    ARGEN CORPORATION, THE·D818122069·Dental porcelain/ceramic restoration kit

    OEC FLUOROTRAK 9800 PLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    JOURNEY UNICONDYLAR TIBIAL BASEPLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 30, 2026

    ABBOCATH - T INTRAVENOUS CATHETER, 14G 140MM

    FDA Adverse Event
    Injury ·HOSPIRA, INC.·Product code FOZ·May 15, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 19, 2014

    LCS COM RPSFLEX FEM CEM L STD+

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·June 9, 2011

    UNKNOWN DEEP BRAIN STIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·December 27, 2010

    UNKNOWN DEEP BRAIN STIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·December 27, 2010

    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