4,774 results · 20ms · Sources: EU EUDAMED, US FDA

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval
FDA Class 3 ·VITRAX OPHTHALMIC SURGICAL AID

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Avalus Bioprosthesis, Avalus Ultra Bioprosthesis

Intraocular Lens

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

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SYNCARDIA COMPANION 2 DRIVER SYSTEM

Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval
FDA Class 3 ·Urovysion Bladder Cancer Kit

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Medtronic CoreValve Evolut PRO TAV, and Avalus Bioprosthesis

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL UPB365 POSTERIOR CHAMBER INTRAOCULAR LENSES

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B) RABBIT MONOCLONAL PRIMARY ANTIBODY

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·TIER A LENS MODEL 722D

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-t) SYSTEM

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

Artificial Heart

FDA Pre-Market Approval
FDA Class 3 ·Total Artificial Heart

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Bellafill Dermal Filler

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·ARTEFILL® - PMMA COLLAGEN DERMAL FILLER

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 304 (ULTRA C-LOOP)

System, Rf/Microwave Hyperthermia, Cancer Treatment

FDA Pre-Market Approval
FDA Class 3 ·BSD 1000 HYPERTHERMIA SYSTEM