BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MINICLINIC OVULATION PREDICTION TEST

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OXYGEN & AEROSOL THERAPY

    FDA Adverse Event
    Malfunction ·UNOMEDICAL S.A. DE C.V.·Product code CAF·May 28, 2014

    L9000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·November 17, 2010

    ACCH-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·December 28, 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