Sensor, Glucose, Invasive

FDA classification

FDA Class 3 ·Sensor, Glucose, Invasive

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

Reagents For Molecular Diagnostic Test Systems

FDA classification

FDA Class 1 ·Reagents For Molecular Diagnostic Test Systems

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

Neurologic Disease Risk Assessment Molecular Test

FDA classification

FDA Class 2 ·Neurologic Disease Risk Assessment Molecular Test

Respiratory Panel

FDA classification

FDA Class 2 ·Respiratory Panel

Isocapnic Ventilation Device

FDA classification

FDA Class 2 ·Isocapnic Ventilation Device

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

FDA classification

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

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Test, Albumin Cobalt Binding

FDA classification

FDA Class 2 ·Test, Albumin Cobalt Binding

Placental Alpha Microglobulin-1 Immunoassay

FDA classification

FDA Class 3 ·Placental Alpha Microglobulin-1 Immunoassay

Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

FDA classification

FDA Class 2 ·Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Low Dead Space Needle, Single Lumen, Hypodermic

FDA classification

FDA Class 2 ·Low Dead Space Needle, Single Lumen, Hypodermic

Assay For Detection Of Proteases In Chronic Wounds

FDA classification

FDA Class 2 ·Assay For Detection Of Proteases In Chronic Wounds

Dislodger, Stone, Flexible, Ureteral, Reprocessed

FDA classification

FDA Class 2 ·Dislodger, Stone, Flexible, Ureteral, Reprocessed

Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

FDA classification

FDA Class 2 ·Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System

Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

FDA classification

FDA Class 2 ·Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

Ovarian Adnexal Mass Assessment Score Test System

FDA classification

FDA Class 2 ·Ovarian Adnexal Mass Assessment Score Test System

Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

FDA classification

FDA Class 2 ·Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

Candida Species Nucleic Acid Detection System

FDA classification

FDA Class 2 ·Candida Species Nucleic Acid Detection System