8,447 results · 21ms · Sources: EU EUDAMED, US FDA

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status)

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·S660 2.75 WITH DISCRETE TECHNOLOGY OTW CORONARY STENT SYSTEM

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval
FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis with and without InhibiZone

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Valiant Thoracic Stent Graft with the Captivia Delivery System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·TALENT AAA STENT GRAFT WITH XCELERANT HYDRO DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

Shunt, Portosystemic, Endoprosthesis

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

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Valiant Thoracic Stent Graft with the Captivia Delivery System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·Epic Self-Expanding Nitinol Vascular Stent with Delivery System

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval
FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·EverFlex™ Self-Expanding Peripheral Stent with Entrust™ Delivery System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·TALENT AAA STENT GRAFT WITH XCELERANT HYRO DELIVERY SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT)

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

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

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·S670 AND S660 WITH DISCRETE TECHNOLOGY CORONARY STENT SYSTEMS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·POWERLINK STENT GRAFT WITH 17FR. INTUITRAK ACCESSORY DELIVERY SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT )