3,572 results · 41ms · Sources: EU EUDAMED, US FDA

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·FOCUS(R) & NEWVUES(R) SOFT CONTACT LENSES

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

FDA Pre-Market Approval
FDA Class 3 ·DIASORIN ETI MAK-2 PLUS ASSAY

Sera, Reactive And Non-Specific Control, Fta-Abs Test

FDA classification
FDA Class 2 ·Sera, Reactive And Non-Specific Control, Fta-Abs Test

Ava-Fa Kft.

Authorized representative
🇭🇺 Hungary

Piccolo Liver Panel Plus

FDA UDI
ABAXIS, INC.·EABA40000031·The Piccolo® Liver Panel Plus, used with the Pi...

Human Lyophilized Dura Mater

FDA classification
FDA Class 2 ·Human Lyophilized Dura Mater

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

PICCOLO PRIMARY HEALTH PANEL

FDA registration
ABAXIS, INC.·12 products·🇺🇸 United States

Immunoglobulin G (Igg) Infusion System

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

Pure EP

FDA UDI
BIOSIG TECHNOLOGIES, INC.·00856750007000·PURE EP™ is a system consists of two main parts...

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)

Infinity Creatinine

FDA registration
Fisher Diagnostics·13 products·🇺🇸 United States

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

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

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