Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOCURVE SOFT CONTACT LENSES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 600/700/800/900 & ENPULSE FAMILIES OF PACEMAKERS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK MODIFIED ORIFICE, MODIFIED ORIFICE II AORTIC BIOPROSTHESES

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANCURE ENDOGRAFT SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RX5000 PROGRAMMER

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·WALL STENT ILIAC ENDOPROSTHESIS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·HYDROVIEW IOL BLANK MATERIAL

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC MARQUIS MODEL 7277 DUAL CHAMBER ICD SYSTEM

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·ECLIPSE TMR HOLMIUM LASER SYSTEM

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING