230 results · 30ms · Sources: EU EUDAMED, US FDA

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ADATO SIL-O1 5000 SILICONE OIL

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·IC-8 Apthera Intraocular Lens (IOL)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·EC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES FOR EXTENDED WEAR (UP TO 7 DAYS/6 NIGHTS OF EXTENDED WEAR)

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval
FDA Class 3 ·enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T)

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·TECHNOLAS TENEO™ 317 (MODEL 2) Excimer Laser System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·O2 OPTIX (LOTRAFILCON B) AND NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·CLEAR SOFT (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Axium Neurostimulator System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·BRIO NEUROSTIMULATION SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval
FDA Class 3 ·PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·STAARVISC II

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ISERT PY-60AD

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ISERT MODEL PC-60AD PACKAGING IMPROVEMENT