BEUDAMED
    12 results · 30ms · Sources: EU EUDAMED, US FDA

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    LipiVage

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

    AMBU Co2 Detector

    FDA UDI
    WESTMED, INC.·05707480101146·Carbon Dioxide Detector w/ Adapter

    TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ONE USE PLUS MICROKERATOME

    FDA Adverse Event
    Injury ·MORIA SA·Product code HMY·November 18, 2020

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 5, 2025

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAM·June 17, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 22, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 19, 2008

    VERSAFITCUP CC TRIO NO-HOLE ACETABULAR SHELL Ø 48

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 23, 2017

    BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 22GA 1.00IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·July 29, 2022

    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