Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS PRESCRIPTION INSERTS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL HEMOSTATIC MATRIX

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE GLOBAL IMPENDENCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER MUSCULAR VSD OCCLUDER

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

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

FDA Pre-Market Approval

FDA Class 3 ·CERAMIC TRANSCEND HIP ARTICULATION SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVOCES (OVD), HEALON GV, HEALON5 PRODUCTS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Zenith Fenestrated AAA Endovascular Graft

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY AB ACETABULAR SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Mobi-C Cervical Disc Prosthesis

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·BRYAN (TM) CERVICAL DISC

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MitraClip System (NT)

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline Flex Embolization Device (PFED)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator

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

FDA Pre-Market Approval

FDA Class 3 ·LCS(R) Total Knee System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·WRAPSODY Cell-Impermeable Endoprosthesis

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·LAP BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM