Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·GEM 21S GROWTH FACTOR ENHANCED MATRIX

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene Cryotherapy Device

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·CRYSTALENS AND TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR

Acute Coronary Syndrome Event Detector

FDA Pre-Market Approval

FDA Class 3 ·Guardian System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Voyant Monthly, Voyant Monthly Premium, Voyant Monthly Toric, Voyant Monthly Multifocal

Enzyme Immunoassay, Fetal Fibronectin

FDA Pre-Market Approval

FDA Class 3 ·FULLTERM FETAL FIBRONECTIN TEST

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GENESYS HTA SYSTEM

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·Visian Toric ICL (Implantable Collamer Lens)

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

FDA Pre-Market Approval

FDA Class 3 ·HeartLogic™

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED 3 Defibrillator with Uni-Padz

Continuous Glucose Monitor, Implanted, 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

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Toric1-Piece Intraocular Lenses (IOLs) Models ZCT300 and ZCT400

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon Kit

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI XT DR/VR SureScan, Evera MRI S DR/VR SureScan and Visia AF MRI VR SureScan and Implantable Cardioverter Defibr

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·DePuy Ceramax Ceramic Total Hip System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT THORACIC STENT GRAFT SYSTEM