BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    CLINIFACTS 200 DATA MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NUVASIVE SPHERX II SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ToeTac™ 10° Hammertoe Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPSUREFIX NOVUS

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

    KAPPA 400 DR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DXY·October 8, 2010

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·November 6, 2012

    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 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