Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Orbera Intragastric Balloon

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Integrity Zotarolimus-Eluting Coronary Stent System

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire UAS High AHI/High BMI

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRTRAKS Clinical Study

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TREO Abdominal Stent-Graft System

Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

FDA Pre-Market Approval

FDA Class 3 ·OPRA System

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·KAMRA INLAY

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·M6-C Artificial Cervical Disc

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·OBALON BALLOON SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve System / Medtronic CoreValve Evolut R System/ Medtronic CoreValve Evolut PRO System

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM

Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

FDA Pre-Market Approval

FDA Class 3 ·OPRA Implant System

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Prometra Programmable Infusion Pump System

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Ranger Paclitaxel-Coated PTA Balloon Catheter

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·INCRAFT AAA Stent Graft System

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System