Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·TECHNOLAS 217A EXCIMER LASER SYSTEM

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXIFIRST(TM) FETAL SENSOR FS14-SERIES

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·SCHNEIDER PTCA CATHETERS

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY TFC UNITE PRODUCT LINE

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ARRAY MULTIFOCAL ULTRAVIOLET ABSORBING SILICONE POSTERIOR CHAMBER IOL

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·CHARITE ARTIFICIAL DISC

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·ACUVUE BRAND (ETAFILCON A) DAILY EXTENDED WEAR CONTACT LENS

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY THREADED FUSION CAGE(TFC)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·UV-ABSORBING PMMA POSTERIOR CHAMBER IOLS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFTCON(VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENS(EXTENDED WEAR)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA INTAOCULAR LENS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR DS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·TMX-2000 BPH THERMOTHERAPY SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANEURX STENT GRAFT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CSI(CROFILCON A)EXTENDED WEAR SOFT

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·HYDROGENICS 60 (OCUFILICON F) UV IMT SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ALLERGAN SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER IOL