System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Dc-Defibrillator, High Energy, (Including Paddles)

FDA classification

FDA Class 3 ·Dc-Defibrillator, High Energy, (Including Paddles)

Device, Intrauterine, Contraceptive And Introducer

FDA classification

FDA Class 3 ·Device, Intrauterine, Contraceptive And Introducer

System, Balloon, Intra-Aortic And Control, Reprocessed

FDA classification

FDA Class 3 ·System, Balloon, Intra-Aortic And Control, Reprocessed

Apparatus, Electronanesthesia

FDA classification

FDA Class 3 ·Apparatus, Electronanesthesia

Prosthesis, Hip, Constrained, Metal

FDA classification

FDA Class 3 ·Prosthesis, Hip, Constrained, Metal

Metal Cemented Constrained Femorotibial Knee Prosthesis

FDA classification

FDA Class 3 ·Metal Cemented Constrained Femorotibial Knee Prosthesis

Microsphere, Trace

FDA classification

FDA Class 3 ·Microsphere, Trace

Band, Tubal Occlusion

FDA classification

FDA Class 3 ·Band, Tubal Occlusion

Pacemaker, Bladder

FDA classification

FDA Class 3 ·Pacemaker, Bladder

Kit, Balloon Repair, Catheter

FDA classification

FDA Class 3 ·Kit, Balloon Repair, Catheter

Transcervical Contraceptive Tubal Occlusion Device

FDA classification

FDA Class 3 ·Transcervical Contraceptive Tubal Occlusion Device

Stimulator, Carotid Sinus Nerve

FDA classification

FDA Class 3 ·Stimulator, Carotid Sinus Nerve

Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal

FDA classification

FDA Class 3 ·Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal

Valve, Tubal Occlusion

FDA classification

FDA Class 3 ·Valve, Tubal Occlusion

Clip, Tubal Occlusion

FDA classification

FDA Class 3 ·Clip, Tubal Occlusion

Device, Impotence, Mechanical/Hydraulic

FDA classification

FDA Class 3 ·Device, Impotence, Mechanical/Hydraulic

Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)

FDA classification

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

Plethysmograph, Ocular

FDA classification

FDA Class 3 ·Plethysmograph, Ocular

Implanted Cerebellar Stimulator

FDA classification

FDA Class 3 ·Implanted Cerebellar Stimulator