10,000 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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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
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
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
Cardiac Ablation Percutaneous Catheter
FDA Pre-Market Approval
FDA Class 3
·CHILLI II COOLED ABLATION SYSTEM
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
FDA Pre-Market Approval
FDA Class 3
·POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Elecsys total PSA, total PSA CalSet II
Dressing, Wound And Burn, Interactive
FDA Pre-Market Approval
FDA Class 3
·APLIGRAF
Implant, Cochlear
FDA Pre-Market Approval
FDA Class 3
·COMBI 40+ COCHLEAR IMPLANT SYSTEM
Agent, Absorbable Hemostatic, Collagen Based
FDA Pre-Market Approval
FDA Class 3
·COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS
Stent, Coronary
FDA Pre-Market Approval
FDA Class 3
·EXPRESS/EXPRESS2 MR & OTW CORONARY STENT SYSTEMS