98 results · 20ms · Sources: EU EUDAMED, US FDA

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval
FDA Class 3 ·ISPAN PERFLUOROPROPANE C3F8 GAS

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM

System, Laser, Fiber Optic, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 HE, CONTAK RENEWAL E RF, CONTAK RENEWAL 3 RF HE W/CONSULT PROG SFTWR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·ADVISA SR MRI

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

Artificial Iris

FDA classification
FDA Class 3 ·Artificial Iris

Ophthalmic Sealant

FDA classification
FDA Class 3 ·Ophthalmic Sealant

Phakic Toric Intraocular Lens

FDA classification
FDA Class 3 ·Phakic Toric Intraocular Lens

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

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval
FDA Class 3 ·VIDAS TOTAL PSA

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·VIDAS FREE PSA RT

Gases Used Within Eye To Place Pressure On Detached Retina

FDA classification
FDA Class 3 ·Gases Used Within Eye To Place Pressure On Detached Retina

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

FDA classification
FDA Class 3 ·Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)