1,920 results · 20ms · Sources: EU EUDAMED, US FDA

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 150A 150SE ULTRA VOILET-ABSORB. POSTERIOR

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY

Artificial Heart

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

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·PLIOLENS UV ABSORBING SILICONE POST. CHAM. IOL

System, Rf/Microwave Hyperthermia, Cancer Treatment

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

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MMR RxDx Panel

Intraocular Lens

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

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 ·UV/ABSORBING POSTERIOR CHAMBER IOL MODEL UPB330GS

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-L1 (SP263) CDx Assay

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Bella Skin Test Tray

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 720M ULTRAVIOLET LIGHT-ABSORBING LENS (POST)

System, Rf/Microwave Hyperthermia, Cancer Treatment

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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-Ll (SP263) Assay

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER 2INEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-Ll (SP263) Assay

Replacement Heart-Valve

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

Artificial Heart

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

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval
FDA Class 3 ·Avalus Bioprosthesis