10,000 results
·
42ms
·
Sources: EU EUDAMED, US FDA
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·ENDURANT STENT GRAFT SYSTEM
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
FDA Pre-Market Approval
FDA Class 3
·MEDTRONIC SELECTSECURE LEAD MODEL 3830
Bone Grafting Material, Dental, With Biologic Component
FDA Pre-Market Approval
FDA Class 3
·GEM 21S GROWTH FACTOR ENHANCED MATRIX
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·XIENCE V NANO, XIENCE PRIME XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; HI-TORQUE PROGRESS, PILOT GUIDE
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·ADVIA IMS PROSTATE SPECIFIC ANTIGEN ASSAY (PSA)
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·NAVISTAR RMT CATHETER (4MM)
Device, Hemostasis, Vascular
FDA Pre-Market Approval
FDA Class 3
·MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY
Permanent Defibrillator Electrodes
FDA Pre-Market Approval
FDA Class 3
·CAPSURE SP NOVUS LEAD,CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD,IMPULSE II LEAD
Stent, Superficial Femoral Artery, Drug-Eluting
FDA Pre-Market Approval
FDA Class 3
·ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
Stent, Carotid
FDA Pre-Market Approval
FDA Class 3
·RX ACCULINK CAROTID STENT SYSTEM
Intervertebral Fusion Device With Bone Graft, Lumbar
FDA Pre-Market Approval
FDA Class 2
·RAY TFC AND RAY TFC UNITE
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
FDA Pre-Market Approval
FDA Class 3
·QUICKSITE/QUICKFLEX/EPIC HF/+HF/II HF/II +HF/ATLAS HF/ATLAS + HF/ATLAS II HF/ATLAS II + HF/PROMOTE/PROMOTE +
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (3% SODIUM HYALURONATE), MODEL VT585
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
FDA Pre-Market Approval
FDA Class 3
·OXFORD PARTIAL KNEE SYSTEM-TIBIAL TRAYS
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·ACRYSOF IQ TORIC IOLS
Sensor, Glucose, Invasive, Non-Adjunctive
FDA Pre-Market Approval
FDA Class 3
·DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
System, Appendage Closure, Left Atrial
FDA Pre-Market Approval
FDA Class 3
·Amplatzer Amulet Left Atrial Appendage Occluder
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·Resolute Integrity Zotarolimus-Eluting Coronary Stent System
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·TREO Abdominal Stent-Graft System
System, Endovascular Graft, Aortic Aneurysm Treatment
FDA Pre-Market Approval
FDA Class 3
·GORE TAG Thoracic Endoprosthesis product family