10,000 results · 25ms · Sources: EU EUDAMED, US FDA

Catheter, Balloon, Transcervical

FDA classification
FDA Class 3 ·Catheter, Balloon, Transcervical

Electrode, Clip, Fetal Scalp (And Applicator)

FDA classification
FDA Class 3 ·Electrode, Clip, Fetal Scalp (And Applicator)

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA classification
FDA Class 3 ·Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

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

Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

FDA classification
FDA Class 3 ·Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

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

Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA classification
FDA Class 3 ·Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

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

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

System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)

FDA classification
FDA Class 3 ·System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)

System, Telethermographic (Sole Diagnostic Screen)

FDA classification
FDA Class 3 ·System, Telethermographic (Sole Diagnostic Screen)

System, Thermographic, Liquid Crystal (Sole Diagnostic Screen)

FDA classification
FDA Class 3 ·System, Thermographic, Liquid Crystal (Sole Diagnostic Screen)

System, Telethermographic, Infrared

FDA classification
FDA Class 3 ·System, Telethermographic, Infrared

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

Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA classification
FDA Class 3 ·Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

FDA classification
FDA Class 3 ·Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer

Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury

FDA classification
FDA Class 3 ·Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury