BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    POWDERED LATEX SURGEON'S GLOVE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PSYCHEMEDICS COCAINE EIA

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SUNPEX TECHNOLOGIES MODEL SE 01

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GMK-PRIMARY TIBIAL INSERT FIXED PS SIZE 6/12MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·September 7, 2017

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 19, 2025

    FLEXIBLE SILICONE DRILL DRIVER

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HTW·July 6, 2023

    V.A.C THERAPY

    FDA Adverse Event
    Injury ·KCI USA INC.·Product code OMP·May 15, 2013

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Other ·STRYKER MEDICAL·Product code INK·June 1, 2011

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·August 13, 2008

    MEDISLIM

    FDA Adverse Event
    Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

    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