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

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS) Lung System

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

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS™) Lung System

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

FDA Pre-Market Approval

FDA Class 3 ·Organ Care System (OCS™) Lung System

Test System, For Drugs Of Abuse

FDA classification

FDA Class 3 ·Test System, For Drugs Of Abuse

Tissue Graft Of Less Than 6mm

FDA classification

FDA Class 3 ·Tissue Graft Of Less Than 6mm

Extended Depth Of Focus Intraocular Lens

FDA classification

FDA Class 3 ·Extended Depth Of Focus Intraocular Lens

Tissue Graft Of 6mm And Greater

FDA classification

FDA Class 3 ·Tissue Graft Of 6mm And Greater

Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

FDA classification

FDA Class 3 ·Osseoanchored Prostheses For The Rehabilitation Of Transfemoral Amputees

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA classification

FDA Class 3 ·Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

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

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

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