2,574 results · 44ms · Sources: EU EUDAMED, US FDA

Tissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations

FDA Pre-Market Approval
FDA Class 3 ·TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval
FDA Class 3 ·PearlMatrix™ Bone Graft

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

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

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

Führungsdraht Stahl Teflon-beschichtet

Basic UDI-DI
EU MDD · Eu Md Class 2a ·EPflex Feinwerktechnik GmbH·1 device

Human Lyophilized Dura Mater

FDA classification
FDA Class 2 ·Human Lyophilized Dura Mater

Immunology

FDA registration
Diamond Diagnostics Inc.·10 products·🇭🇺 Hungary

VIDAS 3

FDA registration
BIOMERIEUX ITALIA-INDUSTRIAL DIV.·10 products·🇮🇹 Italy

Immunology

FDA registration
DIAMOND DIAGNOSTICS Inc·10 products·🇺🇸 United States

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

Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

FDA classification
FDA Not Classified ·Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

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