45 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
×
Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
FDA Pre-Market Approval
FDA Class 3
·DAKOCYTOMATION EGFR PHARMDX
Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
FDA Pre-Market Approval
FDA Class 3
·EGFR pharmDx
Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
FDA Pre-Market Approval
FDA Class 3
·EGFR pharmDx
Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
FDA Pre-Market Approval
FDA Class 3
·EGFR pharmDx
Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
FDA Pre-Market Approval
FDA Class 3
·EGFR pharmDx
Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
FDA Pre-Market Approval
FDA Class 3
·DAKOCYTOMATION EGFR PHARMDX KIT
Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
FDA Pre-Market Approval
FDA Class 3
·DAKO EGFR PHARMDX KIT
Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
FDA Pre-Market Approval
FDA Class 3
·EGFR pharmDx
Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
FDA classification
FDA Class 3
·Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RHA 2, RHA 3, RHA 4
Mr-Guided Focused Ultrasound System
FDA Pre-Market Approval
FDA Class 3
·Exablate Model 4000 Type 1.0 & Type 1.1 System (Exablate Neuro)
Sealant, Dural
FDA Pre-Market Approval
FDA Class 3
·DURASEAL DURAL SEALANT SYSTEM
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RHA® Redensity Mepi, RHA®2 Mepi, RHA®3 Mepi, RHA®4 Mepi
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RADIESSE Injectable Implant, RADIESSE Hands, and RADIESSE (+) Lidocaine Dermal Filler
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·RADIESSE Injectable Implant
Agent, Bulking, Injectable For Gastro-Urology Use
FDA Pre-Market Approval
FDA Class 3
·COAPTITE Injectable Implant
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur® and Atellica® IM AFP, ADVIA Centaur® and Atellica® IM PSA, ADVIA Centaur® and Atellica® IM cPSA
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·Adiva Centaur Complexed PSA (cPSA) Immunoassay and Atellica IM cPSA Immunoassay
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·ADVIA Centaur and Atellica IM cPSA
Antigen(Complexed),Prostate Specific,(Cpsa)
FDA Pre-Market Approval
FDA Class 3
·BAYER IMMUNO 1 COMPLEXED PSA ASSAY