44 results · 19ms · Sources: EU EUDAMED, US FDA

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL)

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VERIFLEX (LIBERTE) MONORAIL CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Stent, Coronary

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

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·LOTUS Edge Valve System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·9600CR Crimper

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval
FDA Class 3 ·Relay Thoracic Stent-Graft With Plus Delivery System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Single-Piece PMMA Posterior Chamber IOL

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Single-Piece PMMA Anterior Chamber IOLs

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval
FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM-OLL2, OSL2, ASU, ASB

Microspheres Radionuclide

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

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·TheraSphere

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·SIR-Spheres Y-90 resin microspheres

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·SIR-Spheres Y-90 resin microspheres

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·SIR-SPHERES

Fluorescence Imaging For Breast Cancer Detection

FDA Pre-Market Approval
FDA Class 3 ·Lumicell Direct Visualization System (DVS)

Fluorescence Imaging For Breast Cancer Detection

FDA Pre-Market Approval
FDA Class 3 ·Lumicell Direct Visualization System (DVS)

Microspheres Radionuclide

FDA Pre-Market Approval
FDA Class 3 ·TheraSphere