BEUDAMED
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    ALP (ALKALINE PHOSPHATASE) REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471159419·SAGITTAL BLADE - DE SOUTTER STANDARD 5.5 x 35 x...

    Plateau-X Spacer System

    FDA UDI
    Life Spine, Inc.·00190837012434·

    AccuLIF TL and PL Cage

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO: CARDIMA ABLATION SYSTEM

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

    PLUM XLM W/MODIFD B

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2014

    PROXIMATE*ILS CURVED CIR STAPL

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 7, 2010

    PROLENE POLYPROPYLENE SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAW·December 6, 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

    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