845 results · 20ms · Sources: EU EUDAMED, US FDA

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·myChoice CDx

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-L1 (SP142) Assay

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·COBAS EGFR MUTATION TEST V2

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·TruSight Oncology Comprehensive

Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal

FDA classification
FDA Class 3 ·Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal

Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

FDA classification
FDA Class 3 ·Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

FDA classification
FDA Class 3 ·Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented

FDA classification
FDA Class 3 ·Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic, Cemented

Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

FDA classification
FDA Class 3 ·Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

Immunohistochemistry Antibody Assay, C-Kit

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MEDICAL SYSTEMS PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·xT CDx

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

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

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·THERASCEEN EGFR RGQ PCR KIT

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval
FDA Class 3 ·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) PRIMARY ANTIBODY

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA classification
FDA Class 3 ·Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented