BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    IRIDERM, MODEL APEX 800

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

    THE VERSA-BED

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MODIFICATION TO MODIFIED HD GUIDE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REPLY

    FDA Adverse Event
    Injury ·SORIN CRM S.R.I.·Product code NVZ·March 1, 2013

    VITATRON DA+ T-SERIES DR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code DXY·August 8, 2014

    SPRINT

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI 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

    PM 1260 ASSURITY + 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