8,447 results · 30ms · Sources: EU EUDAMED, US FDA

Stent, Urethral, Prostatic, Semi-Permanent

FDA Pre-Market Approval
FDA Class 3 ·SPANNER TEMPORARY PROSTATIC STENT WITH DISTAL CURVE DESIGN CHANGE

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

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WaveLight EX500 Laser System with Patient Bed Swivel 1125

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

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·LIVEWIRE TC STEERABLE ELECTROPHYSIOLOGY CATHETER WITH UNIVERSAL TEMPERATURE MONITORING

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 ·MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

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

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ)

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

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

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK(TM)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM

Prosthesis, Penis, Inflatable

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

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval
FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P)

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

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

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

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

System, Endovascular Graft, Aortic Aneurysm Treatment

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

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·ROTATIONAL ANGIOPLASTY SYSTEM WITH ROTALINK PLUS EXCHANGEABLE CATHETER/ADVANCER

Stent, Superficial Femoral Artery

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