BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ETEST FLUCONAZOLE FL 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code NGZ·May 7, 2021

    ETEST FLUCONAZOLE FL 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code NGZ·May 7, 2021

    ETEST FLUCONAZOLE FL 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code NGZ·May 7, 2021

    ETEST FLUCONAZOLE FL 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code NGZ·May 7, 2021

    ETEST FLUCONAZOLE FL 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code NGZ·May 7, 2021

    ETEST FLUCONAZOLE FL 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code NGZ·May 7, 2021

    ETEST FLUCONAZOLE FL 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code NGZ·May 7, 2021

    ETEST FLUCONAZOLE FL 256 WW S30

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, SA·Product code NGZ·May 7, 2021

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074036762·BONE SCREW 7040560 ILIAC 5.5X60 TI

    TruForm

    FDA UDI
    Rmo, Inc.·00885797100023·MN 1MOL BD KT STD NO/L R&L 176

    PORTRAIT FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNTHES (USA) RESORBABLE TACK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MESH, SURGICAL

    FDA Adverse Event
    Injury ·W. L. GORE AND ASSOCIATES, INC.·Product code FTM·August 12, 2023

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·March 11, 2013

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·March 18, 2011

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 11, 2008

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013