5,912 results · 20ms · Sources: EU EUDAMED, US FDA

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PMMA Posterior Chamber Intraocular Lenses

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, HEALON ULTIMATE DUAL PACK, AND HEALON DUET

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA Pre-Market Approval
FDA Class 3 ·VYSIS ALK BREAK APART FISH PROBE KIT AND PROBECHEK ALK NEGATIVE CONTROL SLIDES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TECNIS TORIC 1-PIECE INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL AC-21 OMNIFIT ANTERIOR CHAMBER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SOFLENS (POLYMACON) CONTACT LENSES

Excimer Laser System

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BIOFINITY

System, Identification, Contact Lens

FDA Pre-Market Approval
FDA Class 3 ·SOFTMARK

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS B-13F (P-10) & B-1H (P-11)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SOFLENS

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD L1 IHC 22C3 pharmDx

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·Guardant360 CDx

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·CRCDx RAS Mutation Detection Assay Kit

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval
FDA Class 3 ·MONOPREP PAP TEST

Fluid, Intraocular

FDA Pre-Market Approval
FDA Class 3 ·Perfluoron

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·IOL LENS MODEL GR1A

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·VISCOAT, DISCOCISC Ophthalmic Viscosurgical Device