BEUDAMED
    13 results · 24ms · Sources: EU EUDAMED, US FDA

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    PhantomMSK

    FDA 510(k)
    FDA Class 2 ·Radiology

    PROPELLER HEAD SCREW SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304269965·

    AED

    FDA UDI
    NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657016223·Grasper, Semi Rigid, DA, 5FR

    FINE JECT INSULIN PEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NUVASIVE SPHERX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDTRONIC

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code KWQ·July 22, 2011

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 10, 2013

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 8, 2014

    MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT, SMOOTH

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·October 24, 2019

    MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·January 10, 2020

    CPX4 PLUS SMOOTH TALL HEIGHT 550CC

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·April 19, 2022

    CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·February 22, 2021

    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