BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    CTXX85

    FDA 510(k)
    FDA Class 2 ·Radiology

    Bernafon

    FDA UDI
    Bernafon AG·05711584079744·AQ CO7 MNR T, 2.4G NFM DPB COBR ACCUQ

    CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BODYMETRIX BX2000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GYNECARE TVT SECUR SYSTEM

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

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·August 4, 2014

    K-WIRE, INSERTER

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 23, 2011

    TRUE METRIX AIR

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·April 6, 2021

    AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    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