BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    Vantage Galan 3T, MRT-3020, V6.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACDF STAND ALONE CERVICAL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·October 8, 2025

    EASYRA GLU-H REAGENT, MODEL 10200

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MIXED MEDIA MARKER

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

    ACDF STAND ALONE CERVICAL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·April 25, 2025

    ACDF STAND ALONE CERVICAL

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·December 22, 2025

    I-STAT E3+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·March 31, 2020

    CORE IMPACTION DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·October 22, 2014

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø5 PREASSM

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code NKB·June 27, 2013

    THRIATHLON PS FEM COMP #8R-CEM

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS LIMERICK·Product code JWH·June 30, 2011

    ACDF 03.18.118 MECTA-C SA TIPEEK CAGE 18X15X6X7°

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OVE·May 12, 2023

    ACDF STAND ALONE CERVICAL

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OVE·June 13, 2025

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018

    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