Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ReShape Integrated Dual Ballon System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Master Intellis Spinal Cord Stimulation Systems

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject Trabecular Micro-Bypass System

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ENROUTE Transcarotid Stent System

Drug-Coated Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix Drug Coated Balloon

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·LVIS and LVIS Jr.

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·Zilver PTX Drug-Eluting Peripheral Stent

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·Patient-Fitted TMJ Reconstruction Prosthesis System

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Multiple Use Blood Lancet For Multiple Patient Use

FDA classification

FDA Class 3 ·Multiple Use Blood Lancet For Multiple Patient Use

Tissue Adhesive Internal Use

FDA classification

FDA Class 3 ·Tissue Adhesive Internal Use

Tissue Adhesive For Internal Use

FDA classification

FDA Class 3 ·Tissue Adhesive For Internal Use

Implant, Dermal, For Aesthetic Use

FDA classification

FDA Class 3 ·Implant, Dermal, For Aesthetic Use

Tissue Adhesive For Ophthalmic Use

FDA classification

FDA Class 3 ·Tissue Adhesive For Ophthalmic Use

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA classification

FDA Class 3 ·Continuous Glucose Monitor, Implanted, Adjunctive Use

Implant, Collagen For Non-Aesthetic Use

FDA classification

FDA Class 3 ·Implant, Collagen For Non-Aesthetic Use

Sensor, Glucose, Implanted, Non-Adjunctive Use

FDA classification

FDA Class 3 ·Sensor, Glucose, Implanted, Non-Adjunctive Use

System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)

FDA classification

FDA Class 3 ·System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)

Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use

FDA classification

FDA Class 3 ·Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use

Medical Computers And Software For Ophthalmic Use

FDA classification

FDA Class 3 ·Medical Computers And Software For Ophthalmic Use