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

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    SYSTEMATE CREATININE TEST (CREA) #65413

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Marienfeld Superior

    FDA UDI
    Paul Marienfeld GmbH & Co. KG·04250317346186·

    AVR Super-Slide Mitral Valve Retractor

    FDA UDI
    KOROS U.S.A., INC.·10840199538376·AVR Super-Slide Mitral Valve Retractor Small 20...

    PATHO DX LATEX AGGLUTINATION STREP B KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    COMPUTERIZED ANESTHESIA RECORDING & INFO NETWORK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024143197·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024143173·

    VerSys®

    FDA UDI
    Zimmer, Inc.·00889024143180·

    STAPLE, IMPLANTABLE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 25, 2014

    DUROM US ACETABULAR COMPONENT 52/46 L

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·December 27, 2012

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·November 5, 2010

    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