337 results · 21ms · Sources: EU EUDAMED, US FDA

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA classification
FDA Class 3 ·Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·SONATATI100 COCHLEAR IMPLANT

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

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

Optoacoustic Imaging System

FDA Pre-Market Approval
FDA Class 3 ·Imagio® Breast Imaging system

Optoacoustic Imaging System

FDA Pre-Market Approval
FDA Class 3 ·Imagio Breast Imaging System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·SONATA TI 100 COCHLEAR IMPLANT

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·PARADIGM REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA classification
FDA Class 3 ·System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

Immunohistochemistry Antibody Assay, C-Kit

FDA classification
FDA Class 3 ·Immunohistochemistry Antibody Assay, C-Kit

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·BD Onclarity™ HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·BD Onclarity HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·BD Onclarity HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·BD Onclarity HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·BD ONCLARITY HPV ASSAY

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS