Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED AB5000 CIRCULATORY SUPPORT SYSTEM

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR MUTATION TEST v2

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Stent, Central Venous

FDA classification

FDA Class 3 ·Stent, Central Venous

Pulmonary Stent

FDA classification

FDA Class 3 ·Pulmonary Stent

Prosthesis, Posterior Spinal Elements

FDA classification

FDA Class 3 ·Prosthesis, Posterior Spinal Elements

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA classification

FDA Class 3 ·Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

Intraocular Pressure Lowering Implant

FDA classification

FDA Class 3 ·Intraocular Pressure Lowering Implant

Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·COBAS HPV TEST

Bone, Heterograft

FDA classification

FDA Class 3 ·Bone, Heterograft

Ventricular Bypass (Assist) Device

FDA classification

FDA Class 3 ·Ventricular Bypass (Assist) Device

Intracranial Coil-Assist Stent

FDA classification

FDA Class 3 ·Intracranial Coil-Assist Stent

Immunocytochemistry Assay, P16/Ki-67

FDA classification

FDA Class 3 ·Immunocytochemistry Assay, P16/Ki-67

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA classification

FDA Class 3 ·Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA classification

FDA Class 3 ·System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

Immunohistochemistry Assay, Antibody, Met

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Met

Condom, Female, Animal Tissue

FDA classification

FDA Class 3 ·Condom, Female, Animal Tissue