BEUDAMED
    11 results · 35ms · Sources: EU EUDAMED, US FDA

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    OXY-TWO

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111222986·GUYON SOUND W/THREAD 24FR

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209110193·

    XSTAT 30, 3-PACK, XSTAT 30, 1-PACK

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

    INION OTPS BIODEGRADABLE DISTAL RADIUS PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Death ·W.L. GORE & ASSOCIATES·Product code MIH·February 29, 2016

    OT VERIO IQ METER

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

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·October 4, 2010

    6.0MM TI PANGEA(TM) POLYAXIAL SCR DUAL CORE/40MM THRD LENGTH

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code NKB·November 30, 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