45 results · 17ms · Sources: EU EUDAMED, US FDA

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