Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·CHARITE ARTIFICIAL DISC

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Cont

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Ophthalin, Anikavisc, Nuvisc

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·RADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE (SOE) DELIVERY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX® Ceramic Total Hip System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (TIPS,ILIAC,VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Lotrafilcon A and B Soft Contact Lenses for Daily and Extended Wear

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·AcrySof ReSTOR Posterior Chamber Intraocular Lenses

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·Superion Indirect Decompression System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS/EXPRESS2 MR/OTW CORONARY STENT SYSTEM

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·Implantable Pulse Generator Test Magnet

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (with the AutonoMe Pre-Loaded Delivery System) Claeron Toric Asphe

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AcrySof Posterior Chamber Intraocular Lens

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·ARTEGRAFT COLLEGEN VASCULAR GRAFT

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (TIPS,ILIAC,VENOUS) ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS