Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·XMI AND XMI-RX THROMBECTOMY CATHETERS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET XMI AND XMI-RX CATHETERS

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT Thermocool Electrophysiology Catheter, EZ Steer Thermocool Nav Bi-Directional Electrophysiology Catheter, T

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Thermocool SmartTouch Bi-Directional Navigation Catheter, Thermocool SmartTouch Uni-Directional Navigation Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·QDOT Micro Uni-Directional Navigation Catheter, QDOT Micro Bi-Directional Navigation Catheter

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

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer NAV DS Bi-Directional Electrophysiology Catheter, NAVISTAR DS Electrophysiology Catheter

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Theermocool SF NAV Bi-Directional Catheter

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET RHEOLYTIC XMI THROMBECTOMY CATHETER

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET ULTRA THROMBECTOMY SYSTEM (XMI CATHETER)

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire UAS High AHI/High BMI

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET ULTRA XMI, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMBECTOMY SET'S

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET ULTRA XMI, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMBECTOMY SETS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET ULTRA XMI/SPIROFLEX/SPIROFLEX VG/DISTAFLEX THROMBECTOMY SET'S

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·AngioJet Ultra XMI / Spiroflex / Spiroflex VG / Distaflex Thrombectomy Set

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·POSSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM-ANGIOJET XMI-RX+CATHETER

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation (DBS) Legacy Charger Systems and Accessories

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Spinal Cord Stimulation (SCS) Legacy Charger Systems and Accessories

Neuromodulator For Obesity

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO RECHARGEABLE SYSTEM

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·TransPyloric Shuttle/TransPyloric Shuttle Delivery Device

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·PHYSIO-STIM(TM) I & II MODEL 6000 & 7000