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

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX Ceramic Total Hip System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·prodisc® C

Cap, Cervical, Contraceptive

FDA Pre-Market Approval

FDA Class 3 ·FEMCAP

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

FDA Pre-Market Approval

FDA Class 3 ·NEW JERSEY LCS(TM) TOTAL KNEE SYSTEM

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·MONOVISC INJECTABLE INTRA-ARTICULAR DEVICES

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

FDA Pre-Market Approval

FDA Class 3 ·REFLECTION CERAMIC ACETABULAR HIP (RCHS) SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR EXCIMER LASER SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·LOTRAFILCON SOFT CONTACT LENSES

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

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·STAARVISC II, OPTIVISC/ANIKAVISC/SODIUM HYALURONATE

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO),

Acid, Hyaluronic, Intraarticular

FDA Pre-Market Approval

FDA Class 3 ·EUFLEXXA

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M)

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)

Ring, Endocapsular

FDA Pre-Market Approval

FDA Class 3 ·RingJect and Capsular Tension Ring (CTR)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·enVista® hydrophobic acrylic IOL, enVista® toric hydrophobic aryclic IOL, enVista® Aspire™ hydrophobic acrylic IOL, enVi

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CHAMBER LENS MODELS G187G, G786B, G787B

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·COMPACT DISINFECTING UNIT