BEUDAMED
    17 results · 26ms · Sources: EU EUDAMED, US FDA

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    CarriGen PF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ophthalmic Retractor

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100967·DESMARRES LID RETRACTOR #1

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·August 6, 2002

    CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OSSTAPLE CHILL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·March 30, 2019

    8.0MM/3.2MM DRILL SLEEVE 200MM

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code LXH·April 12, 2017

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·June 4, 2019

    UNK E-LUMINEXX BILIARY STENT

    FDA Adverse Event
    Death ·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code FGE·November 18, 2019

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 17, 2014

    GYNECARE TVT SECUR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code PAH·June 21, 2013

    DELTA XL

    FDA Adverse Event
    Malfunction ·DRAEGER MEDICAL SYSTEMS, INC. (IT/M)·Product code MHX·June 23, 2011

    UNK E-LUMINEXX BILIARY STENT

    FDA Adverse Event
    Injury ·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code FGE·November 14, 2019

    12.0MM/8.0MM PROTECTION SLEEVE188MM

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code LXH·April 12, 2017

    3.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTW·April 12, 2017

    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