2,427 results · 50ms · Sources: EU EUDAMED, US FDA

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·DIASORIN ETI-HA-IGMK PLUS

X-CUBE 70

FDA UDI
Alpinion Medical Systems Co., Ltd.·08800013540003·The X-CUBE 70 diagnostic ultrasound system is i...

X-CUBE i8

FDA UDI
Alpinion Medical Systems Co., Ltd.·08800013542007·The X-CUBE i8 diagnostic ultrasound system is i...

X-CUBE i9

FDA UDI
Alpinion Medical Systems Co., Ltd.·08800013543004·The X-CUBE i9 diagnostic ultrasound system is i...

X-CUBE 90

FDA UDI
Alpinion Medical Systems Co., Ltd.·08800013541000·The X-CUBE 90 diagnostic ultrasound system is i...

X-CUBE 60

FDA UDI
Alpinion Medical Systems Co., Ltd.·08800013545008·The X-CUBE 60 diagnostic ultrasound system is i...

X-CUBE 50

FDA UDI
Alpinion Medical Systems Co., Ltd.·08800013544001·The X-CUBE 50 diagnostic ultrasound system is i...

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS

Human Lyophilized Dura Mater

FDA classification
FDA Class 2 ·Human Lyophilized Dura Mater

Igg (Fd Fragment Specific), Antigen, Antiserum, Control

FDA classification
FDA Class 1 ·Igg (Fd Fragment Specific), Antigen, Antiserum, Control

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
DIASORIN ETI-CORE-IGMK PLUS ASSAY

Immunoglobulin G (Igg) Infusion System

FDA classification
FDA Class 2 ·Immunoglobulin G (Igg) Infusion System

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

FDA Pre-Market Approval
FDA Class 3 ·ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)

Infusion Pump, Drug Specific, Pharmacy-Filled

FDA classification
FDA Class 2 ·Infusion Pump, Drug Specific, Pharmacy-Filled

Digital Pathology Display

FDA classification
FDA Class 2 ·Digital Pathology Display

System, Suction, Lipoplasty

FDA classification
FDA Class 2 ·System, Suction, Lipoplasty

Immunohistochemistry Assay, Antibody, Met

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

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·ELECSYS ANTI-HCV II TEST SYSTEM

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

FDA Pre-Market Approval
FDA Class 3 ·ELECSYS ANTI-HBC TEST SYSTEM