BEUDAMED
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    Contour ProtégéAI

    FDA 510(k)
    FDA Class 2 ·Radiology

    SmartAdjust technology

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RobPath® Total Hip Application

    FDA 510(k)
    FDA Class 2 ·Neurology

    RIATA ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE-SINGAPORE·Product code FRN·August 25, 2011

    RENAISSANCE 26 P-WASS 10/04

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·July 12, 2013

    OMNIPOD 5 CONTROLLER

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code QFG·August 17, 2022

    St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126.

    FDA Recall
    Terminated ·St Jude Medical CRMD·Product code MCX·March 20, 2007

    Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code NIK·August 28, 2017

    Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter

    FDA Recall
    Terminated ·St Jude Medical Cardiac Rhythm Management Division·Product code NVZ·December 18, 2014

    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 Recall
    Terminated ·St Jude Medical Inc.·Product code DXY·August 28, 2017

    Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

    FDA Recall
    Terminated ·St Jude Medical Inc.·Product code LWS·March 31, 2016

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP 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 Recall
    Terminated ·St Jude Medical Inc.·Product code NKE·August 28, 2017

    SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia

    FDA Recall
    Terminated ·St Jude Medical CRMD·Product code MXC·March 31, 2011

    Merlin PCS 3650 programmer Model 3330 software

    FDA Recall
    Open, Classified ·St. Jude Medical, Cardiac Rhythm Management Division·Product code DXY·June 17, 2022

    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 Recall
    Terminated ·St Jude Medical Inc.·Product code DXY·August 28, 2017

    Merlin.net model MN5000 Software

    FDA Recall
    Open, Classified ·St. Jude Medical, Cardiac Rhythm Management Division·Product code DXY·June 17, 2022

    PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST 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 Recall
    Terminated ·St Jude Medical Inc.·Product code LWP·August 28, 2017

    Merlin 2 PCS MER37000 programmer Model MER3400 software

    FDA Recall
    Open, Classified ·St. Jude Medical, Cardiac Rhythm Management Division·Product code DXY·June 17, 2022

    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 Recall
    Terminated ·St Jude Medical Inc.·Product code NKE·August 28, 2017