BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    Black Diamond™ POCT Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bernafon

    FDA UDI
    Bernafon AG·05714464010257·AO5 MNR T R MSIL ALIGO 5 GPL

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112762·BARRON VACUUM PUNCH 7.75MM

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707098102·EXACONNECT PLUS 2.2 ANG. 7,5° GH1,5

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·August 7, 2002

    CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Medical Protective Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TEMA ELBOW SYSTEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code JDB·September 26, 2024

    PROLENE POLYPROPYLENE SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAW·November 5, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

    SURGIWAND II 5MM SUC/IRR W/CAUT/L-HOOK

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC·Product code HET·July 1, 2013

    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