279 results · 21ms · Sources: EU EUDAMED, US FDA

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

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Therapy Cool Path

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·Therapy Cool Path

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·FLEXABILITY ABLATION CATHETER, THERAPY COOL PATH DUO, SAFIRE BLU DUO, COOL PATH DUO, SAFIRE DUO, THERAPY COOL PATH DUO

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·THERAPY COOL PATH CATHETER