2,273 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA Pre-Market Approval
FDA Class 3
·VENTANA ALK (D5F3) CDX ASSAY
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
FDA Pre-Market Approval
FDA Class 3
·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
FDA Pre-Market Approval
FDA Class 3
·XVIVO Perfusion System (XPS) with STEEN Solution Perfusate
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA Pre-Market Approval
FDA Class 3
·VENTANA ALK (D5F3) CDx Assay
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA Pre-Market Approval
FDA Class 3
·VENTANA ALK (D5F3) CDx Assay
Normothermic Preservation System For Transplantation Of Initially Unacceptable Donor Lungs
FDA Pre-Market Approval
FDA Class 3
·XVIVO Perfusion System with STEEN Solution Perfusate
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA Pre-Market Approval
FDA Class 3
·VENTANA ALK (D5F3) CDx Assay
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA Pre-Market Approval
FDA Class 3
·VENTANA ALK (D5F3) CDx Assay
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA Pre-Market Approval
FDA Class 3
·VENTANA ALK (D5F3) CDx Assay
Implant, Dermal, For Aesthetic Use In The Hands
FDA Pre-Market Approval
FDA Class 3
·RADIESSE INJECTABLE IMPLANT
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA Pre-Market Approval
FDA Class 3
·VENTANA ALK (D5F3) CDx Assay
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA Pre-Market Approval
FDA Class 3
·VENTANA ALK (D5F3) CDX ASSAY
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA Pre-Market Approval
FDA Class 3
·VENTANA ALK (D5F3) CDX ASSAY
Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
FDA Pre-Market Approval
FDA Class 3
·VENTANA ALK (D5F3) CDx Assay
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EnVeo R, EnVeo PRO, Evolut PRO+ Delivery Catheter Systems and Loading Systems of the Evolut R, PRO and PRO+ Systems
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems and Loading Systems of the Evolut R/PRO/PRO+ Systems
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·Healon PRO, Healon GV PRO, Healon 5 PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD)
Transcatheter Septal Occluder
FDA Pre-Market Approval
FDA Class 3
·AmplatzerTM PFO Occluder and AmplatzerTM TalismanTM PFO Occluder
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA Pre-Market Approval
FDA Class 3
·Evolut R, Evolut PRO and Evolut PRO+ Systems
Aid, Surgical, Viscoelastic
FDA Pre-Market Approval
FDA Class 3
·Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon® PRO, Healon GV® PRO, Healon5® PRO and Healon® Duet PRO