BEUDAMED
    15 results · 39ms · Sources: EU EUDAMED, US FDA

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    ASAHI PTCA Guide Wire ASAHI SUOH 03

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DRILL 1.5X105MM 22MM STP J-NT

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HBE·June 16, 2021

    DRILL 1.5X105MM 22MM STP J-NT

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HBE·April 28, 2021

    DRILL 1.5X105MM 22MM STP J-NT

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HBE·June 4, 2021

    ADHESIVE ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    TWIST DRILL

    FDA 510(k)
    FDA Class 2 ·Neurology

    WALLSTENT RP ENDOPROSTHESIS

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

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·May 20, 2014

    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

    PAINSMART

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 13, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011

    UNKNOWN ZIMMER DRILL BIT

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code HTW·September 9, 2008

    WALLSTENT? RP ENDOPROSTHESIS

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