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

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    CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HEMO-CATH 10F, HEMO-CATH 12.5F

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 16, 2025

    X-SUIT NIR COVERED BILIARY METALLIC STENT

    FDA Adverse Event
    Malfunction ·MEDINOL LTD.·Product code FGE·December 27, 2017

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·June 8, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 21, 2011

    DELTEC COZMORE

    FDA Adverse Event
    Injury ·SMITH'S MEDICAL·Product code LZG·September 8, 2008

    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

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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