BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    CD TELEMETRY SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327370799·FacialiD-Recon-Priority-4Plates

    B & L OPHTHALMIC INSTRUMENT STAND

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ROOMMATE-OXYGEN CONCENTRATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 31, 2014

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 22, 2010

    MICRO DRILL MEDIUM STRAIGHT ATTACHMENT

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·November 14, 2012

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014