1,019 results · 21ms · Sources: EU EUDAMED, US FDA

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR MUTATION TEST v2

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower™

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR Mutation Test v2

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·BD Onclarity HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·BD Onclarity HPV Assay

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval
FDA Class 3 ·BD Onclarity HPV Assay

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·cobas EGFR Mutation Test v2

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