184 results · 19ms · Sources: EU EUDAMED, US FDA

System, Non-Coherent Light, Photodynamic Therapy

FDA Pre-Market Approval
FDA Class 3 ·CURELIGHT BROADBAND (MODEL CURELIGHT 01)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Natural Eyes Hydra Wear XW and Natural Eyes XW for Astigmatism

ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668

FDA 510(k)
FDA Class 3 ·Cardiovascular

Solution, Cleaning / Lubricating, Artificial Eye

FDA Pre-Market Approval
FDA Class 3 ·ENUCLENE CLEANING/LUBRICATING SOLUTION

Solution, Cleaning / Lubricating, Artificial Eye

FDA Pre-Market Approval
FDA Class 3 ·ENUCLENE(R) OPHTHALMIC SOLUTION

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·ALLEGRETTO WAVE EYE-Q

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Natural Eyes HydraWear XW Extended Parameters, Natural Eyes HydraWear XW for Astigmatism Extended Parameters

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·Natural Eyes HydraWear™ XW Multifocal

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Siello S 45/53/60, Solia S 45/53/60, Siello T 53/60, Siello JT 45/53, Solia T 53/60, Solia JT 45/53, EFH-6F-W

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·ALLEGRETTO WAVE EYE-Q LASER SYSTEM

POWERED EYE WASH

FDA 510(k)
FDA Class 3 ·Unknown

Excimer Laser System

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

Excimer Laser System

FDA Pre-Market Approval
FDA Class 3 ·ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEMS

Excimer Laser System

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

Excimer Laser System

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

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CHANGE IN MANUFACTURING PROCESS TO CLEAN EYE

Excimer Laser System

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

Excimer Laser System

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

OSCOR MEDICAL IMPLANTABLE PACING LEAD, RETRACTABLE

FDA 510(k)
FDA Class 3 ·Cardiovascular

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Siello S and Solia S, EFH-6F-W and DH IS-1/DF4