1,920 results · 21ms · Sources: EU EUDAMED, US FDA

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 ·MODELS 019B, 019C, 019E, 019F, 019J, & 019K

Immunohistochemistry Antibody Assay, C-Kit

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

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock Valved Conduit

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·VALIDATION/GETINGE ETHYLENE OXIDE STERILIZER

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval
FDA Class 3 ·Alinity m HBV

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock Valved Conduit, Model 105

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·Pathway Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody

Immunohistochemistry Antibody Assay, C-Kit

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

Implant, Dermal, For Aesthetic Use

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·CLOSER VASCULAR SEALING SYSTEM

Covered Stent Vascular Connector, Hemodialysis Access Circuit

FDA Pre-Market Approval
FDA Class 3 ·EndoForce Connector for Endovascular Venous Anastomosis

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

FDA Pre-Market Approval
FDA Class 3 ·URO VYSION BLADDER CANCER KIT

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·MODELS UB308E AND UB350ES

Replacement Heart-Valve

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

Implant, Dermal, For Aesthetic Use

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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

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

Replacement Heart-Valve

FDA Pre-Market Approval
FDA Class 3 ·Hancock Valved Conduit Low Porosity

Immunohistochemistry Antibody Assay, C-Kit

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