BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD.

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110935·STERILIZING CASE NARROW

    Zuma-C

    FDA UDI
    Seaspine Orthopedics Corporation·10889981087210·14mm Drill

    POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HOMMED CENTRAL STATION

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ILAB ULTRASOUND IMAGING SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - FREMONT (CE)·Product code OBJ·January 17, 2013

    ARTHROCARE SPORTS MEDICINE RF WAND

    FDA Adverse Event
    Malfunction ·ASCENT HEALTHCARE SOLUTIONS·Product code GEI·November 15, 2010

    AL-III W/FOOT CONTROL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GEY·July 8, 2014

    -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray¿ ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·November 21, 2018