BEUDAMED
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    WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL

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

    WALLSTENT RP ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025

    WALLSTENT ENDOPROSTHESIS

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

    WALLSTENT ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MAF·December 1, 2025

    WALLSTENT? RP ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025

    AGC V2 TOTAL KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·05019279383832·

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704509106·

    DILATING TIP TROCAR WITH STABILITY SLEEVE - 12MM DIAMETER

    FDA Adverse Event
    Injury ·Product code GCJ·June 20, 2006

    ADHESIVE ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    AMS ELEVATE PC

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 8, 2013

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·September 5, 2008

    ALARIS PC UNIT

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FRN·June 23, 2011

    145-DEG PE 38MM CONST HUM LINER +2.5

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 3, 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