BEUDAMED
    14 results · 29ms · Sources: EU EUDAMED, US FDA

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    Endobronchial Tube

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Acetabular Reamers

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215039059·

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161121522510·Bridgeback Acetabular Reamer, Size 51mm

    DASH KNEE

    FDA 510(k)
    FDA Class 2 ·Neurology

    DRYSTAR MODEL 5500

    FDA 510(k)
    FDA Class 2 ·Radiology

    GPC396 GENERAL PURPOSE PROBE COVER

    FDA Adverse Event
    Malfunction ·MICROTEK DOMINICANA, S.A.·Product code KKX·April 4, 2016

    WARMER DRAPE

    FDA Adverse Event
    Malfunction ·MICROTEK DOMINICANA, S.A.·Product code LHC·January 5, 2016

    PEN NDL 32G 4MM HP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·August 22, 2022

    ENRHYTHM

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·June 7, 2013

    COULTER® LH750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·July 7, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 10, 2008

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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