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

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    Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MAT PLATFORM,HYDR,BLUE,4X7'

    FDA UDI
    Hausmann Enterprises, LLC·00840314804563·

    MAT PLATFORM,HYDR,GRAY,4X7'

    FDA UDI
    Hausmann Enterprises, LLC·00840314804570·

    MAT PLATFORM,HYDR,BLACK,4X7'

    FDA UDI
    Hausmann Enterprises, LLC·00840314804594·

    MAT PLATFORM,HYDR,GREEN,4X7'

    FDA UDI
    Hausmann Enterprises, LLC·00840314804587·

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·March 17, 2015

    COROENT INTERLOCK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DRAGON HEART PISTON SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD INTEGRA¿ SYRINGE, 25 G X 1 IN RETRACTING NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·October 17, 2017

    HIRES 90K ADVANTAGE IMPLANT

    FDA Adverse Event
    Injury ·ADVANCED BIONICS, LLC·Product code MCM·October 1, 2014

    CRANIOTOME-ATTACHM F/EPD+APD

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code DZI·June 3, 2013

    TENDRIL DX

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·October 10, 2015

    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