1,055 results · 21ms · Sources: EU EUDAMED, US FDA

Sensor, Glucose, Invasive

FDA classification
FDA Class 3 ·Sensor, Glucose, Invasive

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

Placental Alpha Microglobulin-1 Immunoassay

FDA classification
FDA Class 3 ·Placental Alpha Microglobulin-1 Immunoassay

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

Somatic Gene Mutation Detection System

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

Automated External Defibrillators (Non-Wearable)

FDA classification
FDA Class 3 ·Automated External Defibrillators (Non-Wearable)

Over-The-Counter Automated External Defibrillator

FDA classification
FDA Class 3 ·Over-The-Counter Automated External Defibrillator

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