Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE II LVAS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Base, Patient Connector, Host App, PSA App, Common App, and CareLink SmartSync Platform App

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·HFX App

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Micra AV App, CareLink SmartSync Micra Evolution App, CareLink SmartSync Micra VR App

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync™ Micra VR App, CareLink SmartSync™ Micra AV App

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·NeuroSphere Digital Health Apps

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·BD FOCALPOINT SLIDE PROFILER

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·INFINITY NEUROSTIMULATION SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·INFINITY NEUROSTIMULATION SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Clinician Programmer Application Version 2.0.2, and Liberta RC DBS IPG Firmware Version 1.1.1

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Patient Controller Application Version 2.0.2

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Cobalt, Crome App

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·mySCS™ GO Therapy Controller App

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ICS 3000/EDP 30/CARDIOMESSENGER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Azure Astra App

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HearCare MED-EL, MAESTRO System Software 10.0

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Percepta Serena Solara App

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim DRG IPG Clinical Programmer App

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·EDP 30 EXTERNAL DUAL CHAMBER PACEMAKER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 31301 CARELINK EXPRESS APP.