2,466 results · 20ms · Sources: EU EUDAMED, US FDA

System, Test, Her-2/Neu, Ihc

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

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·BOND ORACLE HER2 IHC SYSTEM

Transcatheter Septal Occluder

FDA Pre-Market Approval
FDA Class 3 ·GORE CARDIOFORM Septal Occluder

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·Bond™ Oracle™ HER2 IHC System

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 22C3 PHARMDX

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval
FDA Class 3 ·BOND ORACLE HER2 IHC SYSTEM

Immunohistochemistry Assay, Antibody, Ki-67

FDA Pre-Market Approval
FDA Class 3 ·Ki-67 IHC pharmDx

Applicator, Hyperthermia, Superficial, Rf/Microwave

FDA Pre-Market Approval
FDA Class 3 ·HYPERTHERMIA SYSTEM 100 A

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GLUCOSE CONTROLLER

Applicator, Hyperthermia, Superficial, Rf/Microwave

FDA Pre-Market Approval
FDA Class 3 ·HYPERTHERMIA SYSTEM 100 A

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GCIIS

Electrode, Stabilized Epidural Spinal

FDA Pre-Market Approval
FDA Class 3 ·SPINAL EPIDURAL ELECTRODE FOR P.E.N.S. MODEL E-355

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GLUCOSE CONTROLLER

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GCIIS

Controller, Closed-Loop Blood Glucose

FDA Pre-Market Approval
FDA Class 3 ·BIOSTATOR GCIIS

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 28-8 PHARMDX (Melanoma Indication)

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD L1 IHC 22C3 pharmDx