Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·ANIMAS VIBE SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVESCAN WAVEFRONT SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IM EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR, S41R EXCIMER LASER SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EON NEUROSTIMULATION SYSTEMS

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LVAS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PERCUTANEOUS VASCULAR CLOSURE SURGICAL (PVS) & SUTURE MEDICATED CLOSURE (SMC) SYSTEMS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PERCUTANEOUS VASCULAR CLOSURE SURGICAL (PVS) & SUTURE MEDICATED CLOSURE (SMC) SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Neuro Cochlear Implant System

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Cordella Pulmonary Artery Sensor System (CorPASS)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Thermocool Smarttouch SF Uni-directional Catheter, Thermocool Smarttouch SF Uni-directional Catheter

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Thermocool Smarttouch Bi-directional Catheter, Thermocool Smarttouch Bi-directional Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·MERLIN 3650 PROGRAMMER

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·NEVRO SENZA SPINAL CORD STIMULATION (SCS) SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER® Smart Mini System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION STEERABLE TIP CATHETER