3,216 results · 18ms · Sources: EU EUDAMED, US FDA

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ZENITH FLEX AAA ENDOVASCULAR GRAFT

Tricuspid Valve Repair Device, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·TriClip G4 System

Mitral Valve Repair Devices

FDA Pre-Market Approval
FDA Class 3 ·MITRACLIP DELIVERY SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Zenith Dissection Endovascular System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

Intravascular Radiation Delivery System

FDA Pre-Market Approval
FDA Class 3 ·NOVOSTE(TM) BETA-CATH SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ZENITH FLEX ENDOVASCULAR GRAFT

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·PERCLOSE PROGLIDE/PERCLOSE AT SUTURE MEDIATED CLOSURE SYSTEMS AND SNARED KNOT PUSHER

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON

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

FDA Pre-Market Approval
FDA Class 3 ·Blazer II XP; Blazer Prime XP

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Blazer II, Blazer II HTD, Blazer Prime HTD

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·DUETT SEALING DEVICE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·CELLPAKER PLASMA COLLECTION DEVICE

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MEDTRONIC WIKTOR RIVAL CORONARY STENT SYSTEM

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval
FDA Class 3 ·ECLIPSE TMR HOLMIUM LASER SYSTEM

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval
FDA Class 3 ·Falope-Ring Band Contraceptive Tubal Occlusion System