Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·Ceramax Ceramic Total Hip System

System, Test, Her-2/Neu, Ihc

FDA classification

FDA Class 3 ·System, Test, Her-2/Neu, Ihc

Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

FDA classification

FDA Class 3 ·Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA classification

FDA Class 3 ·System, Test, Her-2/Neu, Nucleic Acid Or Serum

Extracorporeal Shock Wave Treatment

FDA classification

FDA Class 3 ·Extracorporeal Shock Wave Treatment

Warmer, Blood, Electromagnetic Radiation

FDA classification

FDA Class 3 ·Warmer, Blood, Electromagnetic Radiation

Monitor,Test,Hiv-1

FDA classification

FDA Class 3 ·Monitor,Test,Hiv-1

Molecular Erythrocyte Typing Test

FDA classification

FDA Class 3 ·Molecular Erythrocyte Typing Test

Antibody To Htlv-1, Elisa

FDA classification

FDA Class 3 ·Antibody To Htlv-1, Elisa

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

FDA classification

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

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

System, Separation, Hematopoietic Stem Cell

FDA classification

FDA Class 3 ·System, Separation, Hematopoietic Stem Cell

Kit, Test, Saliva, Hiv-1&2

FDA classification

FDA Class 3 ·Kit, Test, Saliva, Hiv-1&2

Illuminator System For Blood Products

FDA classification

FDA Class 3 ·Illuminator System For Blood Products

System, Test, Home, Hiv-1

FDA classification

FDA Class 3 ·System, Test, Home, Hiv-1

Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury

FDA classification

FDA Class 3 ·Pediatric Extracorporeal Synthetic Semipermeable Membrane Cartridge For Acute Kidney Injury

Kit, Sample Collection, Hiv

FDA classification

FDA Class 3 ·Kit, Sample Collection, Hiv

System, Identification, Hepatitis B Antigen

FDA classification

FDA Class 3 ·System, Identification, Hepatitis B Antigen

Kit, Assay, Estrogen Receptor

FDA classification

FDA Class 3 ·Kit, Assay, Estrogen Receptor

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA classification

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