773 results · 22ms · Sources: EU EUDAMED, US FDA

Respirator, Surgical

FDA classification
FDA Class 2 ·Respirator, Surgical

Prosthesis, Rib Replacement

FDA classification
FDA Class 2 ·Prosthesis, Rib Replacement

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

Limb And Joint Salvage Device With Coating For Bacteria Reduction

FDA classification
FDA Class 2 ·Limb And Joint Salvage Device With Coating For Bacteria Reduction

Software For Endoscopy Procedure Metrics

FDA classification
FDA Class 2 ·Software For Endoscopy Procedure Metrics

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

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

FDA classification
FDA Class 2 ·Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

Test, Methadone, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Methadone, Employment And Insurance Testing, Exempt

Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt

Test, Opiates, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Opiates, Employment And Insurance Testing, Exempt

Test, Codeine, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Codeine, Employment And Insurance Testing, Exempt

Test, Methaqualone, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Methaqualone, Employment And Insurance Testing, Exempt

Test, Amphetamine, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Amphetamine, Employment And Insurance Testing, Exempt

Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt

Test, Cannabinoid, Employment And Insurance Testing, Exempt

FDA classification
FDA Class 2 ·Test, Cannabinoid, Employment And Insurance Testing, Exempt