BEUDAMED
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    SPINNAKER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Bard® Foley Tray with Hydrophilic-Coated Foley Catheter

    FDA UDI
    C. R. Bard, Inc.·00801741024771·Bard® Foley Tray with Hydrophilic-Coated Foley ...

    Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set

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

    QUANTIVA

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010

    SWAN-GANZ BIPOLAR PACING CATHETER (FOR INSERTION VIA SUPERIOR VENA CAVA)

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYG·December 7, 2012

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012