BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Radiology

    HEALIX TI ANCHOR w/DYNACORD

    FDA UDI
    Medos International Sàrl·10886705029938·HEALIX TI ANCHOR w/DYNACORD Titanium Anchor (1)...

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112472·BARRON VACUUM TREPHINE 7.0MM

    LIFESTYLES NATURAL PERSONAL LUBRICANT

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    F 900

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TALENT THORACIC STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·November 6, 2008

    EVIS EXERA II THERAPEUTIC VIDEO DUODENOSCOPE

    FDA Adverse Event
    Other ·OLYMPUS·Product code NWB·August 18, 2011

    ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FRN·July 3, 2013

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MMX·August 20, 2024

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MMX·November 18, 2024

    bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·February 7, 2018

    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