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

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    SuperSonic HepaVu

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814206·GENUMEDI PT SILVER L III

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707040927·DB BRACKETS 22 T+8 A+9 LAT U/L

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694023139·FPS 3.5/4.0mm 6 Hole Oblique T Plate Right

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694077828·FPS 3.5/4.0 6 Hole Oblique Right L Plate Steril...

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    FDA Adverse Event
    Other ·BECTON DICKINSON·Product code NBW·September 30, 2004

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·October 24, 2003

    XLTEK CONNEX IP HEADBOX, MODEL 1054

    FDA 510(k)
    FDA Class 2 ·Neurology

    Pilot Pro Diode Laser

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

    TRABECULAR METAL PRIMARY HIP PROSTHESIS FEMORAL STEM PRESS-FIT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWY·November 19, 2008

    SYNCHRON® CX5 DELTA CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·September 9, 2011

    M2A-38 CUP NON FLARED SIZE 58MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 23, 2013

    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