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

Ventricular Bypass (Assist) Device

FDA classification

FDA Class 3 ·Ventricular Bypass (Assist) Device

Intracranial Coil-Assist Stent

FDA classification

FDA Class 3 ·Intracranial Coil-Assist Stent

Immunocytochemistry Assay, P16/Ki-67

FDA classification

FDA Class 3 ·Immunocytochemistry Assay, P16/Ki-67

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA classification

FDA Class 3 ·Aortic Valve, Prosthesis, Percutaneously Delivered

Wearable Automated External Defibrillator

FDA classification

FDA Class 3 ·Wearable Automated External Defibrillator

Whole Blood Pre-Treatment T-Cell Enrichment Reagent

FDA classification

FDA Class 3 ·Whole Blood Pre-Treatment T-Cell Enrichment Reagent

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA classification

FDA Class 3 ·Tricuspid Valve Repair Device, Percutaneously Delivered

Prosthesis, Mitral Valve, Percutaneously Delivered

FDA classification

FDA Class 3 ·Prosthesis, Mitral Valve, Percutaneously Delivered