1,221 results · 25ms · Sources: EU EUDAMED, US FDA

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

FDA classification
FDA Class 2 ·Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Microbial Colony Image Assessment System

FDA classification
FDA Class 2 ·Microbial Colony Image Assessment System

Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

FDA classification
FDA Class 2 ·Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

FDA classification
FDA Class 2 ·Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

FDA classification
FDA Class 2 ·Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

FDA classification
FDA Class 2 ·Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

FDA classification
FDA Class 2 ·Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

Syringe, Piston, Reprocessed

FDA classification
FDA Class 2 ·Syringe, Piston, Reprocessed

Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers

FDA classification
FDA Class 2 ·Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers

Camera, Ophthalmic, General-Use

FDA classification
FDA Class 2 ·Camera, Ophthalmic, General-Use

Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking

FDA classification
FDA Class 2 ·Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking

Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

FDA classification
FDA Class 2 ·Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

Antigen, Invasive Fungal Pathogens

FDA classification
FDA Class 2 ·Antigen, Invasive Fungal Pathogens

Medication Management System, Remote

FDA classification
FDA Class 2 ·Medication Management System, Remote

System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

FDA classification
FDA Class 2 ·System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection

Kit, Conception-Assist, Home Use

FDA classification
FDA Class 2 ·Kit, Conception-Assist, Home Use

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification
FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

FDA classification
FDA Class 2 ·Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

Cancer Predisposition Risk Assessment System

FDA classification
FDA Class 2 ·Cancer Predisposition Risk Assessment System

Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

FDA classification
FDA Class 2 ·Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings