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

Implant, Corneal, Refractive

FDA Pre-Market Approval
FDA Class 3 ·KAMRA INLAY

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AUTODELFIA HAFP TEST KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AUTODELFIA XPRESS HAFP TEST SYSTEM

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AUTODELFIA HAFP KIT

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval
FDA Class 3 ·AUTODELFIA / DELFIA XPRESS HAFP TEST SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 14760 UV ABSORBING POSTERIOR CHAMBER LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 13060 UV ABSORBING POSTERIOR CHAMBER LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 14760 UV ABSORBING POSTERIOR CHAMBER LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 24070 UV ABSORBING POSTERIOR CHAMBER LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·THREE & SINGLE PIECE BIOCONVEX INTRAOCULAR LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODIFIED LABELING FOR IOL 60 MOS.STERILITY EXPIR.

Intraocular Lens

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

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 14760 UV ABSORBING POSTERIOR CHAMBER LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TIER A MODELS 24050,24150,25050,25350-125 LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TIER A MODELS 24050,24150,25050,25350-125 LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 14660 UV ABSORBING POSTERIOR CHAMBER LENSES

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·ACCUTECH SINGLE & THREE PIECE INTRAOCULAR LENSES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Reply SR, Reply Dr, Esprit SR, Esprit DR (2nd generation , i.e. V2 ) & (5TH generation i.e.V5)

Catheter, Percutaneous (Valvuloplasty)

FDA Pre-Market Approval
FDA Class 3 ·INOUE-BALLOON Catheter