1,114 results · 19ms · Sources: EU EUDAMED, US FDA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SURFILCON A/VASURFILCON A

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock II Bioprosthesis, Models T505 and T510

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS MODELS 305/310/305U

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 II Bioprosthesis

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SAUFLON(R) PW (LIDOFILCON B)

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II PROCINE BIOPROSTHETIC HEART VALVE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK MODIFIED ORIFICE VALVED CONDUIT-(MODEL 150)

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS, MODELS 305 AND 310

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS

Replacement Heart-Valve

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

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MDOEL UPB380 POSTERIOR CHAMBER INTAOCULAR LENS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·HEALON D

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·SOFLOW PW (LIDOFILCON B)

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Freestyle Bioprosthesis

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CEEON ULTRAVIOLET LIGHT-ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS)

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Mosaic Bioprosthesis

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·X-70 SOFT CONTACT LENS

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 721A ULTRAVIOLET LIGHT-ABSORBING LENS (POST)