537 results · 17ms · Sources: EU EUDAMED, US FDA

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

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·Guardian Connect system

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

Immunocytochemistry Assay, P16/Ki-67

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

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

Immunohistochemistry Assay, Antibody, Claudin 18

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Claudin 18

Immunohistochemistry Assay, Antibody, Folr1

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Folr1

Immunohistochemistry Antibody Assay, C-Kit

FDA classification
FDA Class 3 ·Immunohistochemistry Antibody Assay, C-Kit

Immunohistochemistry Assay, Antibody, Met

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Met

Kit, Assay, Progesterone Receptor

FDA classification
FDA Class 3 ·Kit, Assay, Progesterone Receptor

Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

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

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval
FDA Class 3 ·MiniMed 670G System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Obalon Balloon System