Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WaveLight EX500 Laser

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·IMPELLA VENTRICULAR SUPPORT SYSTEMS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·TRANSCYTE (DERMAGRAFT-TC)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MICRO-DRIVER OVER-THE-WIRE CORONARY STENT SYSTEM AND MICRO-DRIVER MX2 CORONARY STENT SYSTEM

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA Pre-Market Approval

FDA Class 3 ·NeuRX Diaphragm Pacing System (DPS)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Automated Breast Ultrasound

FDA Pre-Market Approval

FDA Class 3 ·Invenia ABUS Premium, Invenia ABUS Prime

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·KONTUR 55 EW

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·S670 OVER-THE-WIRE CORONARY STENT SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·GUARDIAN TELEMETERED GLUCOSE MONITORING SYSTEM (TGMS)

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS Total Knee System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LASERSCAN LSX EXCIMER LASER SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM;GFX OVER-THE-WIRE CORONARY STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Silicon-Filled Breast Implants

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C