BEUDAMED
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    SMART LEISH, MODEL LGM1-050

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROPHYPEARLS

    FDA 510(k)
    FDA Class 1 ·Dental

    BD SYRINGE 1ML LS 200 S/C

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·July 3, 2019

    PVA FOAM EMBOLIZATION PARTICLES

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRD·March 26, 2018

    VASOVIEW HEMOPRO 2

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 16, 2013

    ISYMM ASPHERIC INTRAOCULAR LENS

    FDA Adverse Event
    Malfunction ·HOYA SURGICAL OPTICS INC.·Product code HQL·April 5, 2011

    NEXGEN COMPLETE KNEE SOLUTION ARTICULAR SURFACE INSERTION INSTRUMENT

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LXH·July 21, 2008

    BD INTIMA-II 24GAX0.75IN PRN SLM

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·July 18, 2025

    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