BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    MICRO-SAMPLE OSMOMETER 3M0

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EXOSHAPE DUO SOFT TISSUE FASTENER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PROXIMATE STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 27, 2014

    PORTABLE LIQUID OXYGEN UNIT (CYLINDER ONLY,OXYGEN ITSELF IS A DRUG)

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code CAW·November 14, 2012

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 13, 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