Monitor, Lung Water Measurement

FDA Pre-Market Approval

FDA Class 3 ·MODEL 9310 LUNG WATER COMPUTER

Monitor, Lung Water Measurement

FDA Pre-Market Approval

FDA Class 3 ·MODEL 9310 LUNG WATER COMPUTER

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Laser Angle Measurement Tool for Open and Close Leaflet Angles Measurement

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Cardiomems HF Pressure Measurement System

JOINT MEASUREMENT INDICATOR

FDA 510(k)

FDA Class 3 ·Orthopedic

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Open Pivot heart valve

Implant, Anti-Gastroesophageal Reflux

FDA Pre-Market Approval

FDA Class 3 ·Linx Reflux Management System

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE and On-X Ascending Aortic Prothesis

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE WIRE SYSTEMS)

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT SYSTEM (10 MM VENOUS ENDOPROSTHESIS) AND UNISTEP PLUS DELIVERY SYSTEM (12 MM VENOUS ENDOPROSTHESIS)

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT LILAC ENDOPROSTHESIS