BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

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    EAR KNIVES

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    STRYKER T4 HYTREL ZIPPER TOGA

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

    LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    STEAM STER LOCKS ORANGE

    FDA Adverse Event
    Injury ·AESCULAP INC·Product code KCT·October 12, 2016

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 13, 2014

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 20, 2012

    ENVISTA IOL

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·June 10, 2015

    STEAM STER LOCKS ORANGE

    FDA Adverse Event
    Malfunction ·AESCULAP INC·Product code KCT·July 26, 2016

    ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

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

    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; 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