BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    OXY-DIAL

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111221897·GUYON SOUND W/THREAD 18FR

    PANTHER Cutter Stapler

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

    IMAGECAST PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014

    VITALITY

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 4, 2010

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·November 26, 2012

    SMALL TI RIB HOOK

    FDA Adverse Event
    Malfunction ·SYNTHES (U.S.A.) BRANDYWINE·Product code MDI·July 25, 2013

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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