BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    Resolve Modular Revision Hip Stem

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Artman Instruments

    FDA UDI
    Wise Linkers, LLC·D1272423151·Dental Bone Graft Implant Syringe 6mm ARTMAN Brand

    NA

    FDA UDI
    Medos International Sàrl·10886705026203·HD Coupler, C-Mount Zoom 13-28mm

    CEREBRAL STATE MONITOR - CSM

    FDA 510(k)
    FDA Class 2 ·Neurology

    MINOP Disposable Introducer 26F

    FDA 510(k)
    FDA Class 2 ·Neurology

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2023

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·March 12, 2026

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·November 20, 2008

    UNKNOWN DEPUY ACS HIP LINER

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code JDI·September 10, 2011

    ZERO TIP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code FFL·July 9, 2013

    TMC SPEEDMTP

    FDA Adverse Event
    Injury ·TREACE MEDICAL CONCEPTS, INC.·Product code JDR·April 1, 2025

    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