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

FDA classification

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

Aspiration Therapy System

FDA classification

FDA Class 3 ·Aspiration Therapy System

Organ Care System (Ocs) Heart System

FDA classification

FDA Class 3 ·Organ Care System (Ocs) Heart System

Sensor, Glucose, Invasive

FDA classification

FDA Class 3 ·Sensor, Glucose, Invasive

Stent, Urethral, Prostatic, Semi-Permanent

FDA classification

FDA Class 3 ·Stent, Urethral, Prostatic, Semi-Permanent

Absorbable Collagen Hemostatic Agent With Thrombin

FDA classification

FDA Class 3 ·Absorbable Collagen Hemostatic Agent With Thrombin

Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

FDA classification

FDA Class 3 ·Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

Hepatitis Viral B Dna Detection

FDA classification

FDA Class 3 ·Hepatitis Viral B Dna Detection

Intrasaccular Flow Disruption Device

FDA classification

FDA Class 3 ·Intrasaccular Flow Disruption Device

Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy

FDA classification

FDA Class 3 ·Hyperthermia System, Bladder Cancer Treatment, With Chemotherapy

Computer-Assisted Personalized Sedation System

FDA classification

FDA Class 3 ·Computer-Assisted Personalized Sedation System

Drug-Eluting Sinus Stent

FDA classification

FDA Class 3 ·Drug-Eluting Sinus Stent

Cancer-Related Germline Gene Mutation Detection System

FDA classification

FDA Class 3 ·Cancer-Related Germline Gene Mutation Detection System

Atrial Defibrillator

FDA classification

FDA Class 3 ·Atrial Defibrillator

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA classification

FDA Class 3 ·Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

System, Balloon, Intra-Aortic And Control, Reprocessed

FDA classification

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

Cultured Human Cell Skin Dressing

FDA classification

FDA Class 3 ·Cultured Human Cell Skin Dressing

Somatic Gene Mutation Detection System

FDA classification

FDA Class 3 ·Somatic Gene Mutation Detection System

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA classification

FDA Class 3 ·Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA classification

FDA Class 3 ·Implant, Hearing, Active, Middle Ear, Totally Implanted