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

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    SpineView X-Pac Expandable Lumbar Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Logical Constrained Trial Liner 32/52-54mm

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215073008·

    ICUFF REPAIR PLATE, RIGHT; CUFF REPAIR PLATE. LEFT; ANCHOR BOLT, 10MM THROUGH 50MM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COOK FORMULA 418 BILIARY STENT SYSTEM

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

    STYLE 68 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·July 16, 2020

    STARDRIVE SCREWDRIVER SHAFT T8 105MM

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code KWQ·September 27, 2016

    KNIFE

    FDA Adverse Event
    Malfunction ·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·October 6, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 7, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 22, 2011

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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