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

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    TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 13, 2014

    RESTORE RECHARGABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 14, 2010

    PREFYX PPS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code FTL·December 13, 2012

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015