Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CONFILCON A SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VIEWPOINT CK SYSTEM

Prosthesis, Finger, Constrained, Metal/Polymer

FDA Pre-Market Approval

FDA Class 3 ·BRAUN-CUTTER TRAPEZO-METACARPAL PROSTHESIS

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·FALOPE RING BAND AND APPLICATOR SYSTEMS

Fluid, Hysteroscopy

FDA Pre-Market Approval

FDA Class 3 ·DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A)

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

FDA Pre-Market Approval

FDA Class 3 ·THERMATRX OFFICE THERMO THERAPY

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·OPTIGUIDE (TM) CYLINDRICAL FIBER OPTIC

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR 3-Piece Monofocal IOLs, SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS OptiBlue 1-Piece IOL, TECNIS Multifocal 1-

Oximeter, Fetal Pulse

FDA Pre-Market Approval

FDA Class 3 ·OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Foldable Acrylic IOL

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HTA SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA INTAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA INTRAOCULAR LENS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·FLEXTIP PLUS INTRASPINAL CATHETER KIT

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·Light Adjustable Lens (LAL) and Light Delivery Device (LDD)

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire II Upper Airway Stimulator

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity Toric Multifocal