BEUDAMED
    12 results · 18ms · Sources: EU EUDAMED, US FDA

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    KENEX INJECTOR HEAD SUPPORT (AS EXHIBIT 2)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867061637·UNIVERS REVERS RASP SIZE 5

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127021473·Number Five Retractor

    Life Instruments

    FDA UDI
    Life Instrument Corporation·M9307439510050·Hohmann Retractor 10mm

    XRO UMBILICAL CATHETER-CODE 270

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867061644·REAMER GUIDE 135

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867061651·REAMER GUIDE 155

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 8, 2013

    INSIGNIA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 6, 2011

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 22, 2014

    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