BEUDAMED
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    KOSMOS

    FDA 510(k)
    FDA Class 2 ·Radiology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198352·AK3 PS Insert Trial Size 5, 18mm

    CETRA

    FDA UDI
    Orthofix US LLC·18257200134632·4.0mm X 18mm PRIMARY CONSTRAINED SELF-TAPPING S...

    INFINION 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 2, 2023

    TRINITY ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·October 8, 2008

    GUIDINGBLOCK F/2-COLUMN DIST-RAD-PL2.4 6

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code FZX·June 27, 2013

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 21, 2011

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·July 23, 2025

    VALEO / VALEO II

    FDA Adverse Event
    Malfunction ·SINTX TECHNOLOGIES (FORMERLY AMEDICA CORP)·Product code MAX·March 25, 2020

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QMN·November 28, 2023

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    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