2,020 results · 7ms · Sources: EU EUDAMED, US FDA

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Deep Brain Stimulation For The Treatment Of Dystonia

FDA classification
FDA Class 3 ·Deep Brain Stimulation For The Treatment Of Dystonia

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

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

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 Flutter

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

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

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

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

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

Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System

FDA classification
FDA Class 3 ·Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System

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

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

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 Ascending Aorta And Aortic Arch Lesions

FDA classification
FDA Class 3 ·Endovascular System For Treatment Of Ascending Aorta And Aortic Arch 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

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

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

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

Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer

FDA classification
FDA Class 3 ·Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer

Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb

FDA classification
FDA Class 3 ·Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb

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