BEUDAMED
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    StimSite

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Anatomic PEEK™ Cervical Fusion System with Nanotechnology

    FDA UDI
    NANOVIS SPINE, LLC·00814216028037·ANATOMIC PEEK w/ Nano 18 x 16 x 8 x 10°

    SPIROL EPIDURAL CATHETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    UNKNOWN

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·February 16, 2009

    UNKNOWN

    FDA Adverse Event
    Death ·MEDTRONIC NEUROMODULATION·Product code MHY·February 16, 2009

    UNKNOWN

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·February 16, 2009

    UNK

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·February 16, 2009

    UNKNOWN

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·February 16, 2009

    UNKNOWN

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·February 16, 2009

    UNKNOWN

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·February 16, 2009

    UNKNOWN

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·February 16, 2009

    UNKNOWN CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·November 18, 2010

    ITREL II

    FDA Adverse Event
    Death ·MEDTRONIC NEUROMODULATION·Product code MHY·September 16, 2008

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·June 30, 2011

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014

    OSCILL-SAW-ATTACHM-II CRESCENTIC TECHNIQ

    FDA Adverse Event
    Malfunction ·Product code HWE·July 2, 2013

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    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