Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C

Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)

FDA classification

FDA Class 3 ·Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)

Implanted Cerebellar Stimulator

FDA classification

FDA Class 3 ·Implanted Cerebellar Stimulator

Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce

FDA classification

FDA Class 3 ·Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce

Device, Antichoke, Suction

FDA classification

FDA Class 3 ·Device, Antichoke, Suction

Sterilizer, Endodontic Dry Heat

FDA classification

FDA Class 3 ·Sterilizer, Endodontic Dry Heat

Sterilizer, Glass Bead

FDA classification

FDA Class 3 ·Sterilizer, Glass Bead

Prosthesis, Testicle

FDA classification

FDA Class 3 ·Prosthesis, Testicle

Prosthesis, Testicular

FDA classification

FDA Class 3 ·Prosthesis, Testicular

Dilator, Cervical, Expandable

FDA classification

FDA Class 3 ·Dilator, Cervical, Expandable

Stimulator, Neuromuscular, Implanted

FDA classification

FDA Class 3 ·Stimulator, Neuromuscular, Implanted

Monitor, Electroencephalographic, Fetal (And Accessories)

FDA classification

FDA Class 3 ·Monitor, Electroencephalographic, Fetal (And Accessories)

Orthosis, Pneumatic Structure, Rigid

FDA classification

FDA Class 3 ·Orthosis, Pneumatic Structure, Rigid

Prosthesis, Elbow, Hemi-, Humeral, Metal

FDA classification

FDA Class 3 ·Prosthesis, Elbow, Hemi-, Humeral, Metal

Kit, Chemical Snake-Bite

FDA classification

FDA Class 3 ·Kit, Chemical Snake-Bite

Prosthesis, Finger, Constrained, Metal/Polymer

FDA classification

FDA Class 3 ·Prosthesis, Finger, Constrained, Metal/Polymer

Stimulator, Vaginal, Muscle, Powered, For Therapeutic Use

FDA classification

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

Prosthesis, Wrist, Constrained, Metal

FDA classification

FDA Class 3 ·Prosthesis, Wrist, Constrained, Metal

Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented

FDA classification

FDA Class 3 ·Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented

Dilator, Cervical, Vibratory

FDA classification

FDA Class 3 ·Dilator, Cervical, Vibratory