BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    PEDABAROGRAPH

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    PREMIER® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074229188·PLATE 6861260 60MM FSP ANTERIOR CRV

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517157966·CoRoent® XLF, 12x18x60mm

    EndoEssentials™ Gutta Percha Points ISO#60 .02 Taper w MM Markings

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172014663·Polymer-based endodontic gutta percha

    INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ARIZONA OXYGEN TIMER DEVICE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    SLIMLINE SIS ENDO

    FDA Adverse Event
    Malfunction ·LUMENIS, LTD.·Product code GEX·May 20, 2014

    5.5MM SHORT SECONDARY PORT

    FDA Adverse Event
    Malfunction ·USSC PUERTO RICO·Product code GCJ·October 1, 2010

    GPS STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·November 2, 2012

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    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