Automated Insulin Dosing , Threshold Suspend

FDA classification

FDA Class 3 ·Automated Insulin Dosing , Threshold Suspend

Hiv Self-Tests

FDA classification

FDA Class 3 ·Hiv Self-Tests

Joint, Temporomandibular, Implant

FDA classification

FDA Class 3 ·Joint, Temporomandibular, Implant

P2psa

FDA classification

FDA Class 3 ·P2psa

Drug-Eluting Sinus Stent

FDA classification

FDA Class 3 ·Drug-Eluting Sinus Stent

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

FDA classification

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

Cancer-Related Germline Gene Mutation Detection System

FDA classification

FDA Class 3 ·Cancer-Related Germline Gene Mutation Detection System

Atrial Defibrillator

FDA classification

FDA Class 3 ·Atrial Defibrillator

Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

FDA classification

FDA Class 3 ·Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Cultured Human Cell Skin Dressing

FDA classification

FDA Class 3 ·Cultured Human Cell Skin Dressing

Somatic Gene Mutation Detection System

FDA classification

FDA Class 3 ·Somatic Gene Mutation Detection System

Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator

FDA classification

FDA Class 3 ·Mechanical And Enzymatic Autologous Skin Processor For Cell Suspension, For Stable Vitiligo, With Applicator

Transilluminator (Diaphanoscope)

FDA classification

FDA Class 3 ·Transilluminator (Diaphanoscope)

Bone, Heterograft

FDA classification

FDA Class 3 ·Bone, Heterograft

Immunocytochemistry Assay, P16/Ki-67

FDA classification

FDA Class 3 ·Immunocytochemistry Assay, P16/Ki-67

Automated Insulin Dosing Device System, Bihormonal Control

FDA classification

FDA Class 3 ·Automated Insulin Dosing Device System, Bihormonal Control

Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

FDA classification

FDA Class 3 ·Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA classification

FDA Class 3 ·System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

Extracorporeal Shock Wave Treatment

FDA classification

FDA Class 3 ·Extracorporeal Shock Wave Treatment

Automated Insulin Dosing Device System, Single Hormonal Control

FDA classification

FDA Class 3 ·Automated Insulin Dosing Device System, Single Hormonal Control