Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LIFEVEST WEARABLE DEFIBRILLATOR

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MICRO STENT II & GFX OVER-THE-WIRE CORONARY STENT SYSTEMS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-PMMA PCL'S

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100..

Gastric Emptying Breath Test

FDA Pre-Market Approval

FDA Class 3 ·GASTRIC EMPTYING BREATH TEST (GEBT)

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM AND CODMAN 3000 IMPLANTABLE INFUSION PUMP

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·Straumann Emdogain

Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

FDA classification

FDA Class 3 ·Software Option For Anesthesia Gas Machine To Achieve And Maintain Targeted End Tidal Oxygen And Anesthetic Agents

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA classification

FDA Class 3 ·Lens, Contact (Rigid Gas Permeable), Extended Wear

Nitric Oxide Generator And Delivery System

FDA Pre-Market Approval

FDA Class 3 ·LungFit PH

Nitric Oxide Generator And Delivery System

FDA classification

FDA Class 3 ·Nitric Oxide Generator And Delivery System

Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling

FDA classification

FDA Class 3 ·Analyzer, Gas, Nitrogen, Partial Pressure, Blood-Phase, Non-Indwelling

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON (SENOFILCON A) CONTACT LENS MATERIAL

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM