BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE

    FDA 510(k)
    FDA Class 1 ·Dental

    QUANTAI UG REAGENT STRIP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    KODAK MIN-R 2 CASSETTE

    FDA 510(k)
    FDA Class 2 ·Radiology

    MBT CEM KEEL TIB TRAY SZ3

    FDA Adverse Event
    Injury ·DEPUY IRELAND 9616671·Product code NJL·June 26, 2014

    TENDRIL DX

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

    ACCU-CHEK ULTRAFLEX

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code FPA·December 5, 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