Prostate Immobilizer Rectal Balloon

FDA classification

FDA Class 2 ·Prostate Immobilizer Rectal Balloon

Needle, Phacoemulsification, Reprocessed

FDA classification

FDA Class 2 ·Needle, Phacoemulsification, Reprocessed

Table Mounted Miniaturized Electromechanical Surgical System

FDA classification

FDA Class 2 ·Table Mounted Miniaturized Electromechanical Surgical System

Cervical Intraepithelial Neoplasia (Cin) Test System

FDA classification

FDA Class 2 ·Cervical Intraepithelial Neoplasia (Cin) Test System

Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed

FDA classification

FDA Class 2 ·Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed

Integrated Continuous Glucose Monitoring System, Factory Calibrated

FDA classification

FDA Class 2 ·Integrated Continuous Glucose Monitoring System, Factory Calibrated

Tracheal Prosthesis With Cover Material Derived From Human Sources

FDA classification

FDA Class 2 ·Tracheal Prosthesis With Cover Material Derived From Human Sources

Orthosis, Cranial, Laser Scan

FDA classification

FDA Class 2 ·Orthosis, Cranial, Laser Scan

Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

FDA classification

FDA Class 2 ·Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated

Spinal Muscular Atrophy Newborn Screening Test System

FDA classification

FDA Class 2 ·Spinal Muscular Atrophy Newborn Screening Test System

Influenza A Virus Subtype Differentiation Nucleic Acid Assay

FDA classification

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

Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

FDA classification

FDA Class 2 ·Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

FDA classification

FDA Class 2 ·Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

Adjunctive Pain Measurement Device For Anesthesiology

FDA classification

FDA Class 2 ·Adjunctive Pain Measurement Device For Anesthesiology

Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

FDA classification

FDA Class 2 ·Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples

Whole Slide Imaging System

FDA classification

FDA Class 2 ·Whole Slide Imaging System

Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

FDA classification

FDA Class 2 ·Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

Over-The-Counter Device To Assess Risk Of Sleep Apnea

FDA classification

FDA Class 2 ·Over-The-Counter Device To Assess Risk Of Sleep Apnea

Air-Conduction Hearing Aid Software

FDA classification

FDA Class 2 ·Air-Conduction Hearing Aid Software

System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

FDA classification

FDA Class 2 ·System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer