System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

FDA classification

FDA Class 2 ·System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

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)

Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

FDA classification

FDA Class 2 ·Fish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies

Barrier, Adhesion, Cardiovascular

FDA classification

FDA Class 3 ·Barrier, Adhesion, Cardiovascular

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA classification

FDA Class 3 ·Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

FDA classification

FDA Not Classified ·Remote Or Wearable Patient Monitoring Device For Drug Induced Qt Prolongation Monitoring

Anti-Stick Glass Syringe

FDA classification

FDA Not Classified ·Anti-Stick Glass Syringe

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA classification

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

Light Source System, Diagnostic Endoscopic

FDA classification

FDA Class 3 ·Light Source System, Diagnostic Endoscopic

Cultured Epithelial Autograft

FDA classification

Cultured Epithelial Autograft

Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test

FDA classification

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

Gastric Emptying Breath Test

FDA classification

FDA Class 3 ·Gastric Emptying Breath Test

Cardiac Allograft Gene Expression Profiling Test System

FDA classification

FDA Class 2 ·Cardiac Allograft Gene Expression Profiling Test System

Catheter, Peritoneal Dialysis, Single Use, Exempt

FDA classification

FDA Class 2 ·Catheter, Peritoneal Dialysis, Single Use, Exempt

Closed Loop Auto Titration Device For Oral Appliances

FDA classification

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

Over-The-Counter Automated External Defibrillator

FDA classification

FDA Class 3 ·Over-The-Counter Automated External Defibrillator

Cardiac Support Mesh Wrap

FDA classification

FDA Not Classified ·Cardiac Support Mesh Wrap

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

Mechanical Ventilator

FDA classification

FDA Class 2 ·Mechanical Ventilator

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA classification

FDA Class 3 ·Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing