Cap, Cooling (Infants)

FDA classification

FDA Class 3 ·Cap, Cooling (Infants)

Generator, Pulsatile Flow, Cardiopulmonary Bypass

FDA classification

FDA Class 3 ·Generator, Pulsatile Flow, Cardiopulmonary Bypass

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA classification

FDA Class 3 ·Prosthesis, Ankle, Uncemented, Non-Constrained

Lens, Contact, Orthokeratology, Overnight

FDA classification

FDA Class 3 ·Lens, Contact, Orthokeratology, Overnight

Shockwave Intravascular Lithotripsy System

FDA classification

FDA Class 3 ·Shockwave Intravascular Lithotripsy System

Tissue Adhesive Internal Use

FDA classification

FDA Class 3 ·Tissue Adhesive Internal Use

Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA classification

FDA Class 3 ·Covered Stent Vascular Connector, Hemodialysis Access Circuit

Condom, Female, Animal Tissue

FDA classification

FDA Class 3 ·Condom, Female, Animal Tissue

Stimulator, Low Electric Field, Tumor Treatment

FDA classification

FDA Class 3 ·Stimulator, Low Electric Field, Tumor Treatment

Illuminator System For Blood Products

FDA classification

FDA Class 3 ·Illuminator System For Blood Products

Diagnostic Low Electric Field

FDA classification

FDA Class 3 ·Diagnostic Low Electric Field

Cardiac Ablation Percutaneous Catheter

FDA classification

FDA Class 3 ·Cardiac Ablation Percutaneous Catheter

Multiple Use Blood Lancet For Multiple Patient Use

FDA classification

FDA Class 3 ·Multiple Use Blood Lancet For Multiple Patient Use

Biologic Material, Dental

FDA classification

FDA Class 3 ·Biologic Material, Dental

Nitric Oxide Generator And Delivery System

FDA classification

FDA Class 3 ·Nitric Oxide Generator And Delivery System

Electrical Impedance Spectrometer

FDA classification

FDA Class 3 ·Electrical Impedance Spectrometer

Stimulator, Electrical, Implanted, For Essential Tremor

FDA classification

FDA Class 3 ·Stimulator, Electrical, Implanted, For Essential Tremor

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA classification

FDA Class 3 ·Stimulator, Autonomic Nerve, Implanted (Depression)

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA classification

FDA Class 3 ·Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

Intracranial Aneurysm Flow Diverter

FDA classification

FDA Class 3 ·Intracranial Aneurysm Flow Diverter