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

Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

FDA classification

FDA Class 3 ·Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

Transvenous Temporary Phrenic Nerve Stimulator

FDA classification

FDA Class 3 ·Transvenous Temporary Phrenic Nerve Stimulator

Catheter, Neurovasculature, Occluding Balloon

FDA classification

FDA Class 3 ·Catheter, Neurovasculature, Occluding Balloon

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA classification

FDA Class 3 ·Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

Alfapump System

FDA classification

FDA Class 3 ·Alfapump System

Mr-Guided Focused Ultrasound System

FDA classification

FDA Class 3 ·Mr-Guided Focused Ultrasound System

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA classification

FDA Class 3 ·Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement

FDA classification

FDA Class 3 ·Fluorescence In Situ Hybridization, Platelet-Derived Growth Factor Receptor, Beta Polypeptide (Pdgfrb), Rearrangement

Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

FDA classification

FDA Class 3 ·Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement