420 results · 23ms · Sources: EU EUDAMED, US FDA

Influenza A Virus Subtype Differentiation Nucleic Acid Assay

FDA classification
FDA Class 2 ·Influenza A Virus Subtype Differentiation Nucleic Acid Assay

Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating

FDA classification
FDA Class 2 ·Spinal Fusion System With 12-Methacryloyloxydodecyl Pyridinium Bromide (C21h34brno2) Coating

Novel Influenza A Virus, A/H5 Ns1 Protein

FDA classification
FDA Class 2 ·Novel Influenza A Virus, A/H5 Ns1 Protein

Adjunctive Epicardial Vascular Physiologic Status Indicator

FDA classification
FDA Class 2 ·Adjunctive Epicardial Vascular Physiologic Status Indicator

Serpina1 Variant Detection System

FDA classification
FDA Class 2 ·Serpina1 Variant Detection System

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

FDA classification
FDA Class 2 ·Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

FDA classification
FDA Class 2 ·Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

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

Radiological Image Processing Software For Radiation Therapy

FDA classification
FDA Class 2 ·Radiological Image Processing Software For Radiation Therapy

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

FDA classification
FDA Class 2 ·X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

Extracorporeal System For Carbon Dioxide Removal

FDA classification
FDA Class 2 ·Extracorporeal System For Carbon Dioxide Removal

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

Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

FDA classification
FDA Class 2 ·Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna

Implantable Radio Frequency Transponder System

FDA classification
FDA Class 2 ·Implantable Radio Frequency Transponder System

Radiological Software Device To Predict Future Breast Cancer Risk

FDA classification
FDA Class 2 ·Radiological Software Device To Predict Future Breast Cancer Risk

Kit, Conception-Assist, Home Use

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

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