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

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    TYMPANOSCOPE

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    MEM-7102; MEB-7102 EVOKED RESPONSE & ELECTRO RECOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    PATIENT EXAMINATION GLOVE (LATEX)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 16, 2014

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2010

    HOVERROUND CORPORATION

    FDA Adverse Event
    Injury ·HOVEROUND CORP.·Product code ITI·December 31, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    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