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

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    ActiGraph LEAP activity monitor (ActiGraph LEAP)

    FDA 510(k)
    FDA Class 2 ·Neurology

    JMS ROTATING HUB A.V.FISTULA NEEDLE SET

    FDA UDI
    JMS SINGAPORE PTE LTD·08888483005208·A.V.FISTULA 15GX1" BE RH 30CM W/CLAMP

    SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ELECTROMAGNETIC TRANSMITTING STYLET

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

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE.LTD.·Product code FRN·November 18, 2008

    SECURE ACUTE CARE BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 22, 2011

    EON MINI

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013

    Revogene, Catalog no. 610210. IVD test instrument

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

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025