On-Body Injector

FDA classification

FDA Class 2 ·On-Body Injector

Direct-To-Consumer Access Pharmacogenetic Assessment System

FDA classification

FDA Class 2 ·Direct-To-Consumer Access Pharmacogenetic Assessment System

Defect Measurement Tool

FDA classification

FDA Class 2 ·Defect Measurement Tool

Temporary Embolization Assist Device, Peripheral

FDA classification

FDA Class 2 ·Temporary Embolization Assist Device, Peripheral

Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

FDA classification

FDA Class 2 ·Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)

Radiation Therapy Marking Device

FDA classification

FDA Class 2 ·Radiation Therapy Marking Device

Semi-Automated Autologous Skin Graft Harvesting And Application Device

FDA classification

FDA Class 2 ·Semi-Automated Autologous Skin Graft Harvesting And Application Device

Dna And Rna Oncology Controls

FDA classification

FDA Class 2 ·Dna And Rna Oncology Controls

Diabetes Digital Therapeutic Device

FDA classification

FDA Class 2 ·Diabetes Digital Therapeutic Device

Flow Cytometric Test System For Hematopoietic Neoplasms

FDA classification

FDA Class 2 ·Flow Cytometric Test System For Hematopoietic Neoplasms

Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv

FDA classification

FDA Class 2 ·Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

FDA classification

FDA Class 2 ·System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Reverse Central Venous Recanalization System

FDA classification

FDA Class 2 ·Reverse Central Venous Recanalization System

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

FDA classification

FDA Class 2 ·Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

Medial Knee Implanted Shock Absorber

FDA classification

FDA Class 2 ·Medial Knee Implanted Shock Absorber

Temporary Coil Embolization Assist Device

FDA classification

FDA Class 2 ·Temporary Coil Embolization Assist Device

Non-Factor Replacement Product Test System

FDA classification

FDA Class 2 ·Non-Factor Replacement Product Test System

Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

FDA classification

FDA Class 2 ·Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System

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