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

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    VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690197126·Revision Knee Spiral Reamer- Hudson Short Flute...

    STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ADDITIVE EXTENSION SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CAPSURE SP NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·February 9, 2013

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·January 7, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·July 23, 2014

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020