Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (QVD)

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 day (omafilcon A)

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

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM: REMAINING ULTRAHIGH MOLECULAR WEIGHT POLYETHYLENE DEVICES

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

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·R3 DELTA CERAMIC HIP SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·DURALOC OPTION CERAMIC ON CERAMIC HIP SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

FDA Pre-Market Approval

FDA Class 3 ·LCS UNI KNEE SYSTEM

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·COHERENT OPAL PHOTOACTIVATOR

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart System

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart Mini System

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·DIOMED 630 PDT LASER

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER® Smart System

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·VISULAS 690S AND VISULINK PDT/U ADAPTER

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER® Smart System

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart Mini System

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170