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

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    IDEAL IQ SOFTWARE OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776187156·KEVORKIAN TISCHLER PUNCH

    CapnoTrak

    FDA UDI
    Respironics Novametrix, LLC·00884838040038·CapnoTrak CO2/O2 Nasal Cannula

    IgM RID plate package

    FDA UDI
    KENT LABORATORIES INC·B176103411·Radial immunodiffusion plate package for human IgM

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756001809·Cervical Collar

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134110·Trial, TLIF, 27L OB STR 7Deg, 11mm

    PLATEAU-TL

    FDA UDI
    Life Spine, Inc.·00190837028794·PLATEAU-TL Interbody, Convex, Bulleted, 10mm x ...

    BD PARADIGM LINK BLOOD GLUCOSE MONITOR

    FDA Adverse Event
    Other ·BECTON DICKINSON·Product code NBW·February 28, 2006

    ELECSYS TESTOSTERONE CALSET II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PULPDENT CAVITY PREPARATION IV

    FDA 510(k)
    FDA Class 2 ·Dental

    GALAXY G3 MINI 1MM X 2CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·December 5, 2020

    AVEA VENTILATOR

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code CBK·July 17, 2015

    VERSAFITCUP HIGHCROSS LINER

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code MEH·October 26, 2011

    COULTER® LH 750 HEMATOLOGY ANALYXZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·May 9, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    FDA Adverse Event
    Malfunction ·PENUMBRA INC.·Product code NRY·May 17, 2011

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code CFR·April 3, 2008

    Access and Access 2 Immunoassay System

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code CGN·April 3, 2008

    UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron Access Clinical System

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code JJE·April 3, 2008