BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    LUBRICATING JELLY

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ORTHOLOC ANKLE PLATING SYSTEM (APS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEDRON Cervical Spacers

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·January 15, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 5, 2014

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·August 2, 2010

    5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code FPA·December 24, 2013