398 results · 21ms · Sources: EU EUDAMED, US FDA

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval
FDA Class 3 ·Intera 3000 Hepatic Artery Infusion Pump

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System

Kit, Assay, Estrogen Receptor

FDA Pre-Market Approval
FDA Class 3 ·ER-EIA MONOCLONAL

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval
FDA Class 3 ·Optune

Coronary Drug-Eluting Stent

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus Elite Everolimus-Eluting Platinum C

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Agent, Occluding, Vascular, Permanent

FDA Pre-Market Approval
FDA Class 3 ·VenaSeal Closure System

Stent, Coronary

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

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval
FDA Class 3 ·CERAMAX Ceramic Total Hip System

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·LD LLIAC PREMOUNTED STENT SYSTEM

Kit, Assay, Progesterone Receptor

FDA Pre-Market Approval
FDA Class 3 ·PGR-EIA MONOCLONAL

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VERIFLEX CORONARY STENT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·SAPIEN 3 Ultra Transcatheter Heart Valve System (THV)

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval
FDA Class 3 ·FLOSEAL (R) MATRIX HEMOSTATIC SEALANT AND PROCEED (TM) HEMOSTATIC SEALANT

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES

Stent, Carotid

FDA Pre-Market Approval
FDA Class 3 ·XACT CAROTID STENT SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Bellafill Dermal Filler

Agent, Occluding, Vascular, Permanent

FDA Pre-Market Approval
FDA Class 3 ·VENASEAL CLOSURE SYSTEM