8,447 results · 23ms · Sources: EU EUDAMED, US FDA

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Percept™ PC INS with BrainSense™ (Model B35200)

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (with InhibiZone)

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·MiniMed iPro2 CGM System with Enlite Sensor

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·SURGIFLO® Hemostatic Matrix Kit with Thrombin

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline Flex Embolization Device with Shield Technology

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval
FDA Class 3 ·Pipeline™ Flex, Pipeline™ Flex with Shield Technology™

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

FDA Pre-Market Approval
FDA Class 3 ·HeartLight® X3 Catheter with Excalibur Balloon™

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·MiniMed iPro2 CGM System with Enlite Sensor

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·EXCOR blood pumps with Injection Molded Housing

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Trifecta and Trifecta Valve with Glide Technology

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval
FDA Class 3 ·GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis with InhibiZone™

Device, Incontinence, Mechanical/Hydraulic

FDA Pre-Market Approval
FDA Class 3 ·AMS 800™ Artificial Urinary Sphincter with InhibiZone™

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MAGIC WALLSTENT(R) ENDOPROSTHESIS WITH DELIVERY SYSTEM