BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    ULTI GUARD HOME INSULIN SYRINGE CONTAINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACIST 4 FRENCH ANGIOGRAPHIC CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSIGHT GENESIS

    FDA 510(k)
    FDA Class 2 ·Neurology

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC·Product code GJS·August 1, 2011

    PROSPACE PEEK IMPLANT 5 7X8X22MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG AND CO. KG·Product code MAX·June 21, 2013

    TSPACE PEEK IMPLANT 26X11X7MM

    FDA Adverse Event
    Malfunction ·AESCULAP IMPLANT SYSTEMS·Product code MAX·October 30, 2015

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SWINFORD·Product code KDI·March 26, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 10, 2011

    PROFEMUR MODULAR FEMORAL NECK

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·March 28, 2008

    PIIC CLASSIC UPGRADE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·January 24, 2024

    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 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