1,011 results · 20ms · Sources: EU EUDAMED, US FDA

Gastric Emptying Breath Test

FDA classification
FDA Class 3 ·Gastric Emptying Breath Test

Hepatitis Viral B Dna Detection

FDA classification
FDA Class 3 ·Hepatitis Viral B Dna Detection

Pediatric Esophageal Atresia Anastomosis Device

FDA classification
FDA Class 3 ·Pediatric Esophageal Atresia Anastomosis Device

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·Cobas EGFR Mutation Test v2, Cobas DNA and cfDNA Sample Preparation Kit

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA classification
FDA Class 3 ·System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

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

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA classification
FDA Class 3 ·Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

Immunohistochemistry Antibody Assay, C-Kit

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

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System