System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA classification

FDA Class 3 ·System, Test, Tumor Marker, For Detection Of Bladder Cancer

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA classification

FDA Class 3 ·Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA classification

FDA Class 3 ·Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA classification

FDA Class 3 ·Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

FDA classification

FDA Class 3 ·Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

FDA classification

FDA Class 3 ·Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA classification

FDA Class 3 ·Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions

FDA classification

FDA Class 3 ·Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions

Generator, Pulsatile Flow, Cardiopulmonary Bypass

FDA classification

FDA Class 3 ·Generator, Pulsatile Flow, Cardiopulmonary Bypass

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA classification

FDA Class 3 ·Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

FDA classification

FDA Class 3 ·Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA classification

FDA Class 3 ·Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA classification

FDA Class 3 ·Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy

FDA classification

FDA Class 3 ·Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy

Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

FDA classification

FDA Class 3 ·Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

FDA classification

FDA Class 3 ·Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation