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

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    AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704399486·FERGUSON FRAZIER SUCTION TUBE 9 FRENCH SIZE 3

    Echo® Hip System Instrumentation

    FDA UDI
    Biomet Orthopedics, LLC·00887868474576·

    ECHO HIP SYSTEM INSTRUMENTATION

    FDA UDI
    Biomet Orthopedics, LLC·00880304467491·

    AESCULAP PNEUMATIC KERRISON

    FDA 510(k)
    FDA Class 2 ·Neurology

    FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·January 6, 2020

    M2A-MAGNUM MOD HD SZ 48MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 11, 2013

    MITEK VAPR S90 ELECTRODE

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code GEI·July 14, 2011

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·September 9, 2008

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·September 2, 2020

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·May 8, 2020

    MAXZERO NEEDLELESS CONNECTOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·May 8, 2020

    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