Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADVANTIO, INGENIO, VITALIO, FORMIO ESSENTIO, ACCOLADE, PROPONENT, AND ALTRUA 2 SUPPORTED BY LATITUDE CONSULT ONLY) (PACE

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·AED Plus and Fully Automatic AED Plus

Device, Impotence, Mechanical/Hydraulic

FDA classification

FDA Class 3 ·Device, Impotence, Mechanical/Hydraulic

Prosthesis, Penis, Inflatable

FDA classification

FDA Class 3 ·Prosthesis, Penis, Inflatable

Mandibular Condyle Prosthesis

FDA classification

FDA Class 3 ·Mandibular Condyle Prosthesis

Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat

FDA classification

FDA Class 3 ·Diathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat

Stimulator, Neuromuscular, Implanted

FDA classification

FDA Class 3 ·Stimulator, Neuromuscular, Implanted

Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use

FDA classification

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

Implanted Diaphragmatic/Phrenic Nerve Stimulator

FDA classification

FDA Class 3 ·Implanted Diaphragmatic/Phrenic Nerve Stimulator

Stimulator, Intracerebral/Subcortical, Implanted

FDA classification

FDA Class 3 ·Stimulator, Intracerebral/Subcortical, Implanted

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

FDA classification

FDA Class 3 ·Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADAR VISION EXCIMER LASER SYSTEM

Joint, Temporomandibular, Implant

FDA classification

FDA Class 3 ·Joint, Temporomandibular, Implant

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented

FDA classification

FDA Class 3 ·Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

FDA classification

FDA Class 3 ·Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight

FDA classification

FDA Class 3 ·Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight