1,114 results · 20ms · Sources: EU EUDAMED, US FDA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·GENESIS-4 (LIDOFILCON A)

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Mosaic Bioprosthesis and Mosaic Ultra Bioprosthesis

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Avalus

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock II Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK LOW POROSITY VALVED CONDUIT

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS PS-100A,PS-101A,PS-102A,PS-103A,PS-104A IOL

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Avalus Bioprosthesis

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SOFT MATE(R) CLEANING & DISINFECTING SOLN.

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Avalus Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Mosaic Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS MODEL 305 (AORTIC)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 405 SPANFLEX TM IOL

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS MODELS T505/T510

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL UV65 ANTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL UP675 POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS 019B, 019C, 019E, 019F, 019J, & 019K

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CEEON HEPARIN SURFACE MODIFIED UV-LIGHT ABSORBING ANTERIOR CHAMBER (IOLS)

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS 019B, 019C, 019E, 019F, 019J, & 019K

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK APICAL LEFT VENTRICLE CONNECTOR

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL/FOLDABLE IOL MODEL 127(920)