BEUDAMED
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    DTX Studio Assist

    FDA 510(k)
    FDA Class 2 ·Radiology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704283532·LAHEY FINGER RETRACTOR 4 3/4" 2 PRONG SHARP

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011252086200·ceraMotion® Me Shoulder transpa, 20 g / dental ...

    ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    3Shape Ortho System

    FDA 510(k)
    FDA Class 2 ·Dental

    IMP,TSV,3.7,10,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·September 14, 2023

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN·Product code CBK·November 14, 2014

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·September 16, 2011

    TALOS SLR

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code DXY·July 29, 2013

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; 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