BEUDAMED
    10 results · 17ms · Sources: EU EUDAMED, US FDA

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    AERO-MASK ONE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111223334·GUYON SOUND W/THREAD 26FR

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209110148·

    H3+ Holter Recorder

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SMARTSUCTION HARMONY DEVICE

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

    OT VERIO IQ METER

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

    VITALITY 2

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

    PSI KIT: 8.5 FR X 4-1/8 (10 CM)

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DYB·November 14, 2012

    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