Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI LINK RX ZETA CORONARY STENT SYSTEM/ MULTI LINK OTW ZETA CORONARY STENT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 283 PULSE GENERATOR MODEL 370 PROGRAMMER

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·ADJUSTABLE GASTRIC BANDING SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas HBV

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Promote Accel, Promote Quadra, Unify Assura, Quadra Assura, Epic+/HF/HF+/IIHF/II+HF, Atlas +HF/IIHF/II+HF/III+HF

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·KONECT RESILIA Aortic Valved Conduit

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Accent, Assurity, Assurity+, Endurity, Endurity Core, Zenex, Zenus

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3 Left Ventricular Assist System

Lithotripter, Shockwave (For Treating Gallbladder Stones)

FDA Pre-Market Approval

FDA Class 3 ·MEDSTONE STS LITHOTRIPTER

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·EPIC/EPIC+/ATLAS/ATLAS+/CONVERT/CONVERT+ ICDS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MCGHAN MEDICAL SALINE-FILLED BREAST IMPLANTS

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·Visian Implantable Collamer Lens for Myopia

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TIER B MODEL SBUV20-23DO IOL

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards® PERIMOUNT ®Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Progel Pleural Air Leak Sealant