10,000 results · 24ms · Sources: EU EUDAMED, US FDA

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