Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·CentriMag Circulatory Support System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ORSIRO Sirolimus Eluting Coronary Stent System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·G5 Mobile Continuous Glucose Monitoring System

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·coflex Interlaminar Stabilization Device

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL Cochlear Implant System

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre 14 Day Flash Glucose Monitoring System

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP System

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·Raindrop Near Vision Inlay

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·Exablate Model 4000 Type 1.0 and 1.1 Systems

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM Masters HP 15mm Rotatable Mechanical Heart Valve (15 AHPJ-505)

Scaffold, Infrapopliteal, Absorbable

FDA Pre-Market Approval

FDA Class 3 ·Esprit™ BTK Everolimus Eluting Resorbable Scaffold System

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Spiration Valve System

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace® and Sentimag® Magnetic Locatization System (PUV)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Tendril MRI

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA Pre-Market Approval

FDA Class 3 ·OrganOx metra® System