BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    Ziehm Vision RFD 3D

    FDA 510(k)
    FDA Class 2 ·Radiology

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694094146·Swivel Driver Handle, QC

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00887709043381·Three-Station High-Pressure Stopcock Manifold (...

    Puritan Bennett

    FDA UDI
    Covidien LP·20884521134406·Shell with Pressure Port,For Soft Headgear CPAP...

    EVEREST Spinal System

    FDA UDI
    VB Spine LLC·10888857348028·Driver, Height Adjustment Size 25 (Short)

    Z5MLB, Z5MLC

    FDA 510(k)
    FDA Class 2 ·Dental

    OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    HOVEROUND CORPORATION

    FDA Adverse Event
    Injury ·HOVEROUND CORP.·Product code ITI·July 11, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023