Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·ISPAN PERFLUOROPROPANE C3F8 GAS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis/Theon Pericardial Aortic Bioprosthesis with ThermaFix tiss

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Sapien XT Transcatheter Heart Valve

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MemoryShape Silicone Gel-Filled Breast Implants

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED BREAST IMPLANTS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN XT TRANSCATHETER HEART VALVE

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·Hintermann Series H3 Total Ankle Replacement System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VISIBILITY TINTED CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·ACUVUE 2 COLORS BRAND (ETAFILCON A) CONTACT LENS WITH UV BLOCKER

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·CRYSTALENS ACCOMMODATING INTRAOCULAR LENS (IOL) AND TRULIGN TORIC POSTERIOR CHAMBER IOL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lens

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators and Accessories

Intraocular Lens

FDA classification

FDA Class 3 ·Intraocular Lens

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·TRULIGN TORIC WEB-BASED TORIC CALCULATOR

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil