116 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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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