BEUDAMED
    10 results · 17ms · Sources: EU EUDAMED, US FDA

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    LACTATE PRO SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FITC anti-human CD8

    FDA UDI
    BIOLEGEND, INC.·00810034701527·URL: https://www.biolegend.com/en-us/products/f...

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M930798090810·Stainless Frazier Suction 8FR 8" from bend

    Irrigation Tubing Bipolar Cord Set

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK ® TENDER INFUSION SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·February 27, 2013

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·July 21, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·February 7, 2011

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Enforcement
    Class II ·Terminated·Philips Healthcare·February 5, 2014

    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908

    FDA Recall
    Terminated ·Philips Healthcare·Product code NCX·January 13, 2014