BEUDAMED
    21 results · 27ms · Sources: EU EUDAMED, US FDA

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    Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·November 7, 2025

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·January 9, 2026

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·May 23, 2025

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·March 25, 2026

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·October 28, 2025

    LYNX ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·December 12, 2025

    LYNX ULTRA SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·September 4, 2025

    ADVANTAGE FIT ULTRA SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code OTN·April 15, 2026

    SOLID STATE LAMP [LED] HEADLIGHT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CHEMOLOCK, CHEMOLOCK PORT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·June 14, 2024

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code PEA·July 22, 2024

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDS·January 10, 2025

    NATURALYTE

    FDA Adverse Event
    Injury ·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

    DEXTRUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·July 17, 2013

    40" (102 CM) APPX 5.3 ML ADMIN SET W/2 CHEMOLOCK¿

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·June 13, 2025

    Revogene, Catalog no. 610210. IVD test instrument

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