26 results
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15ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing
FDA Pre-Market Approval
FDA Class 3
·BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·cobas EGFR Mutation Test v2
Implant, Dermal, For Aesthetic Use In The Hands
FDA Pre-Market Approval
FDA Class 3
·Restylane Lyft with Lidocaine
Implant, Dermal, For Aesthetic Use In The Hands
FDA Pre-Market Approval
FDA Class 3
·RADIESSE INJECTABLE IMPLANT
Immunohistochemistry Assay, Antibody, Ki-67
FDA Pre-Market Approval
FDA Class 3
·Ki-67 IHC pharmDx
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne CDx (FICDx)
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA Pre-Market Approval
FDA Class 3
·FoundationOne Liquid CDx (F1 Liquid CDx)
Immunohistochemistry Assay, Antibody, Ki-67
FDA Pre-Market Approval
FDA Class 3
·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
Immunohistochemistry Assay, Antibody, Ki-67
FDA Pre-Market Approval
FDA Class 3
·Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
Immunocytochemistry Assay, P16/Ki-67
FDA Pre-Market Approval
FDA Class 3
·CINtec PLUS Cytology
Immunocytochemistry Assay, P16/Ki-67
FDA Pre-Market Approval
FDA Class 3
·CINtec PLUS Cytology
Immunocytochemistry Assay, P16/Ki-67
FDA Pre-Market Approval
FDA Class 3
·CINtec PLUS Cytology
Immunocytochemistry Assay, P16/Ki-67
FDA Pre-Market Approval
FDA Class 3
·CINtec PLUS Cytology
Immunocytochemistry Assay, P16/Ki-67
FDA Pre-Market Approval
FDA Class 3
·CINtec PLUS Cytology
Immunocytochemistry Assay, P16/Ki-67
FDA Pre-Market Approval
FDA Class 3
·CINtec PLUS Cytology
Immunocytochemistry Assay, P16/Ki-67
FDA Pre-Market Approval
FDA Class 3
·CINtec PLUS Cytology
Immunocytochemistry Assay, P16/Ki-67
FDA Pre-Market Approval
FDA Class 3
·CINtec PLUS Cytology
Immunocytochemistry Assay, P16/Ki-67
FDA Pre-Market Approval
FDA Class 3
·CINtec PLUS Cytology
Immunocytochemistry Assay, P16/Ki-67
FDA Pre-Market Approval
FDA Class 3
·CINtec PLUS Cytology
Immunocytochemistry Assay, P16/Ki-67
FDA Pre-Market Approval
FDA Class 3
·CINtec PLUS Cytology