Excimer Laser System

FDA Pre-Market Approval

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

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·SVS APEX (FORMERLY OMNIMED) EXCIMER LASER SYSTEM FOR PHOTOREFRACTIVE KERATECTOMY (PRK)

Excimer Laser System

FDA Pre-Market Approval

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

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·Gel-One

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT, PROGEL EXTENDED APPLICATOR SPRAY TIP16CM/6IN, PROGEL EXTENDED APPLICATOR SPRAY TIP29CM/

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilatation Balloon System with Integrated Embolic Protection

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR S2 EXCIMER LASER SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·Gel-One

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICEL Powder Absorbable Hemostatic Powder

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Simplify® Cervical Artificial Disc

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF SPINAL FUSION STIMULATOR

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

FDA Pre-Market Approval

FDA Class 3 ·UROLOGIX TARGIS SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·PROSTATRON