420 results · 24ms · Sources: EU EUDAMED, US FDA

Electrode, Flexible Suction Coagulator, Reprocessed

FDA classification
FDA Class 2 ·Electrode, Flexible Suction Coagulator, Reprocessed

Screw Sleeve Bone Fixation Device, Spine

FDA classification
FDA Class 2 ·Screw Sleeve Bone Fixation Device, Spine

Laparoscope, General & Plastic Surgery, Reprocessed

FDA classification
FDA Class 2 ·Laparoscope, General & Plastic Surgery, Reprocessed

Continuous Glucose Monitor Secondary Display

FDA classification
FDA Class 2 ·Continuous Glucose Monitor Secondary Display

Indicator, Physical/Chemical, Storage Temperature

FDA classification
FDA Class 2 ·Indicator, Physical/Chemical, Storage Temperature

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification
FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

Rigid Sterilization Container With Software

FDA classification
FDA Class 2 ·Rigid Sterilization Container With Software

Software Algorithm Device To Assist Users In Digital Pathology

FDA classification
FDA Class 2 ·Software Algorithm Device To Assist Users In Digital Pathology

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

FDA classification
FDA Class 2 ·Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

FDA classification
FDA Class 2 ·Blood Pump For Ecmo, Long-Term (> 6 Hours) Use

Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

FDA classification
FDA Class 2 ·Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

Genetic Variant Detection And Health Risk Assessment System

FDA classification
FDA Class 2 ·Genetic Variant Detection And Health Risk Assessment System

Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

FDA classification
FDA Class 2 ·Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

Radiological Computer-Assisted Prioritization Software For Lesions

FDA classification
FDA Class 2 ·Radiological Computer-Assisted Prioritization Software For Lesions

System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

FDA classification
FDA Class 2 ·System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

Computerized Cognitive Assessment Aid

FDA classification
FDA Class 2 ·Computerized Cognitive Assessment Aid

Cardiovascular Machine Learning-Based Notification Software

FDA classification
FDA Class 2 ·Cardiovascular Machine Learning-Based Notification Software

Closed Loop Auto Titration Device For Oral Appliances

FDA classification
FDA Class 2 ·Closed Loop Auto Titration Device For Oral Appliances

Radiological Computer-Assisted Triage And Notification Software

FDA classification
FDA Class 2 ·Radiological Computer-Assisted Triage And Notification Software

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

FDA classification
FDA Class 2 ·Powered Light Based Non-Laser Surgical Instrument With Thermal Effect