10,000 results · 31ms · Sources: EU EUDAMED, US FDA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, E

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval
FDA Class 3 ·Parvovirus B19 IgM Immunoassy (V619IMUS)

System, Endovascular Graft, Aortic Aneurysm Treatment

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

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSAPICAL AND TRANSFEMORAL ACCESSORIES

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·TheraSphereTM Y-90 Glass Microspheres System

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·BSC Wolverine Coronary Cutting Balloon

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval
FDA Class 3 ·H.E.L.P. Futura Apheresis System

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval
FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·AngioJet Rheolytic Thrombectomy System

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·UROLOGIX PROSTATRON SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF

Stent, Renal

FDA Pre-Market Approval
FDA Class 3 ·Express SD Monorail Premounted Stent System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·ENDURANT STENT GRAFT SYSTEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·PROMUS Element Plus Everolimus-Eluting Stent System/Promus PREMIER Everolimus-Eluting Platinum Chronium Coronary Stent S

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval
FDA Class 3 ·UROLOGIX TARGIS SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·Blazer II Cardiac Ablation Catheter and Cable

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

FDA Pre-Market Approval
FDA Class 3 ·Blazer Open Irrigated Cardiac Ablation System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·Rotablator Rotational Angioplasty System Guidewire

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval
FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT,PROBECHEK ALK POSITIVE CONTROL SLIDES KIT,PROBECHEK ALK NEGATIVE CONTROL SLIDES KIT