10,000 results · 44ms · Sources: EU EUDAMED, US FDA

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·SJM MASTERS HP VALVED GRAFT WITH GELWEAVE VALSALVA TECHNOLOGY

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·Cordis Exoseal Vascular Closure Device

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·RF MARINR CATHETERS, RF ENHANCER II CATHETERS, RF CONTRACTR CATHETERS AND RF CONDUCTR CATHETERS

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval
FDA Class 3 ·PEPGEN-P15

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·AF-1 Family of Intraocular Lens (IOL)

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval
FDA Class 3 ·Durasphere Injectable Bulking Agent

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval
FDA Class 3 ·Codman Trufill N-Butyl Cyanoacrylate Liquid Embolic System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval
FDA Class 3 ·AngioJet Rheolythic Thrombectomy Catheter

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·Epic Vascular Self-Expanding Stent System

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·V1. 2A PROGRAMMER SOFTWARE

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·EXOSEAL® Vascular Closure Device

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·Innova Vascular Self-Expanding Stent with Delivery System

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval
FDA Class 3 ·TRUFILL n-BCA Liquid Embolic System

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·V.1 2A PROGRAMMER SOFTWARE

Permanent Pacemaker Electrode

FDA Pre-Market Approval
FDA Class 3 ·TENDRILL PASSIVE PLUS/AU PLUS DX

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS EXPRESS CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTRITEX TUL LEAD SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CADENCE TIERED THERAPY DEFIBRILLATOR SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·TRILOGY/SOLUS II/PARAGON III/PHOENIX III

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AMO ARRAY MULTIFOCAL UV-ABSORBING SILCONE POSTERIOR CHAMBER INTRAOCULAR LENS