Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma

FDA Pre-Market Approval

FDA Class 3 ·PROSORBA COLUMN

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·RESHAPE INTEGRATED DUAL BALLOON SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ALTO2 DR MODEL 624 /ALTO2 VR MODEL 625 ICDS

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Simplify Cervical Artificial Disc

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT EX500 LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT EX500 LASER SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·Nucleus 24 Cochlear Implant System

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·HEART LASER CO2 TMR SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LASERSCAN LSX EXCIMER LASER SYSTEM

Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·ATRICURE SYNERGY ABLATION SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·TCI HEARTMATE 1000A IP LVAS

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·TransPyloric Shuttle/TransPyloric Shuttle Delivery Device

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRESTIGE LP(TM) CERVICAL DISC

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Simplify® Cervical Artificial Disc

Lithotripter, Shockwave (For Treating Gallbladder Stones)

FDA Pre-Market Approval

FDA Class 3 ·MEDSTONE STS LITHOTRIPTER

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRESTIGE LP CERVICAL DISC

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT