Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA classification

FDA Class 3 ·Implant, Hearing, Active, Middle Ear, Totally Implanted

Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

FDA classification

FDA Class 2 ·Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access

Insulin Autoantibody Kit

FDA classification

FDA Class 2 ·Insulin Autoantibody Kit

Burn Resuscitation Decision Support Software

FDA classification

FDA Class 2 ·Burn Resuscitation Decision Support Software

Organophosphate Test System

FDA classification

FDA Class 2 ·Organophosphate Test System

Implantable Bladder-Evacuation Electrical Stimulation System

FDA classification

Implantable Bladder-Evacuation Electrical Stimulation System

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

FDA classification

FDA Class 2 ·Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification

FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Monitor, Extracellular Fluid, Lymphedema, Extremity

FDA classification

FDA Class 2 ·Monitor, Extracellular Fluid, Lymphedema, Extremity

Walker, Mechanical, Poly Vinyl Chloride (Pvc)

FDA classification

FDA Class 1 ·Walker, Mechanical, Poly Vinyl Chloride (Pvc)

Stimulator, Low Electric Field, Tumor Treatment

FDA classification

FDA Class 3 ·Stimulator, Low Electric Field, Tumor Treatment

Bladder System

FDA classification

Bladder System

Catheter, Neurovasculature, Occluding Balloon

FDA classification

FDA Class 3 ·Catheter, Neurovasculature, Occluding Balloon

Lynch Syndrome Test System

FDA classification

FDA Class 2 ·Lynch Syndrome Test System

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA classification

FDA Class 3 ·Stimulator, Autonomic Nerve, Implanted (Depression)

Lens, Contact, For Reading Discomfort

FDA classification

FDA Class 2 ·Lens, Contact, For Reading Discomfort

Setmelanotide Eligibility Gene Variant Detection System

FDA classification

FDA Class 2 ·Setmelanotide Eligibility Gene Variant Detection System

Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

FDA classification

FDA Class 2 ·Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

Immunoassay Blood Test For Amyloid Pathology Assessment

FDA classification

FDA Class 2 ·Immunoassay Blood Test For Amyloid Pathology Assessment

Assay, Enterovirus Nucleic Acid

FDA classification

FDA Class 2 ·Assay, Enterovirus Nucleic Acid