184 results · 27ms · Sources: EU EUDAMED, US FDA

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F

Lens, Intraocular, Accommodative

FDA Pre-Market Approval
FDA Class 3 ·CRYSTALENS SE, MODEL AT-45 SE

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS ITEC PRELOADED DELIVERY SYSTEM

Solution, Cleaning / Lubricating, Artificial Eye

FDA classification
FDA Class 3 ·Solution, Cleaning / Lubricating, Artificial Eye

Extended Depth Of Focus Intraocular Lens

FDA classification
FDA Class 3 ·Extended Depth Of Focus Intraocular Lens

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE MODELS WIDE ANGLE 2.2X AND WIDE ANGLE 2.7X

Artificial Iris

FDA classification
FDA Class 3 ·Artificial Iris

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WaveLight EX500 Laser

Phakic Toric Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·Visian Toric ICL (IMPLANTABLE COLLAMER LENS)

Ophthalmic Sealant

FDA classification
FDA Class 3 ·Ophthalmic Sealant

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·iDESIGNRefractive Studio, STAR Excimer Laser System

Phakic Toric Intraocular Lens

FDA classification
FDA Class 3 ·Phakic Toric Intraocular Lens

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX LASER SYSTEM

Intraocular Pressure Lowering Implant

FDA classification
FDA Class 3 ·Intraocular Pressure Lowering Implant

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA classification
FDA Class 3 ·Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

Telescope, Implantable, Miniature

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT)

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·ALLEGRO TOPOLYZER VARIO

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR

Electrical Impedance Spectrometer

FDA Pre-Market Approval
FDA Class 3 ·NEVISENSE