Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Sapien 3 Ultra Delivery System and Edwards Commander Delivery System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS PCUB-30SEO AND PCUB-32SEO IOL

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards eSheath Introducer Set

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·enVista One Piece Hydrophobic Acrylic Intraocular Lens

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SOLUS,ADDVENT,SOLUS II,SYNCHRONY, PHOENIX III, TRIOLOGY, AFFINITY, INTEGRITY, ENTITY,IDENTITY, VERITY, AND VICTORY PACEM

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·SUPERION INTERSPINOUS SPACER SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDURANT, ENDURANT 11, ENDURANT IIS STENT GRAFT SYSTEM AND ENDURANT II AORTO-UNI-ILIAC(AUI) STENT GRAFT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION MULTI STRATEGY COCHLEAR IMPLANT SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS HBV

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·IDESIGN ADVANCED WAVESCAN STUDIO, STAR EXCIMER LASER SYSTEM

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·ANGELCHIK ANTI-REFLUX PROSTHESIS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SINGLE-PIECE UV-ABSORBING POSTERIOR CHAMBER IOLS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME PUMP (MMT-522, MMT-522K,MMT-722,MMT-722K) & GUARDIAN REAL-TIME MONITOR (CSS7100,CSS7100K)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK CORONARY STENT SYSTEMS

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META II MODEL 1204 CARDIAC PACING SYSTEM