1,816 results · 39ms · Sources: EU EUDAMED, US FDA

Monoglyc

FDA registration
HANSAmed Limited DBA Citagenix·1 product·🇨🇦 Canada

Solon Wooden Applicator

FDA registration
AMD Medicom Inc.·1 product·🇨🇦 Canada

Citagenix

FDA registration
HANSAmed Limited DBA Citagenix·2 products·🇨🇦 Canada

Pulse Oximeter

FDA registration
STAR ELITE·1 product·🇨🇦 Canada

High-Wave

FDA registration
DENPLUS, INC.·1 product·🇨🇦 Canada

PPD MEDITECH, DIV. OF INDUSTRIES PPD INC.

FDA registration
PPD MEDITECH, DIV. OF INDUSTRIES PPD INC.·1 product·🇨🇦 Canada

PPD MEDITECH, DIV. OF INDUSTRIES PPD INC.

FDA registration
PPD MEDITECH, DIV. OF INDUSTRIES PPD INC.·1 product·🇨🇦 Canada

Medical Absorbent Fiber

FDA registration
KOSMA-KARE CANADA INC.·1 product·🇨🇦 Canada

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne CDx (F1CDx)

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval
FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen FGFR RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen KRAS RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen EGFR RGQ PCR Kit

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

FDA Pre-Market Approval
FDA Class 3 ·Praxis Extended RAS Panel

QBC STAR

Basic UDI-DI
EU IVDD · Eu Ivd General ·Drucker Diagnostics·1 device

QBC AccuTube

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Drucker Diagnostics·1 device

Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

FDA Pre-Market Approval
FDA Class 3 ·TOP2A FISH PHARMDX KIT

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

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

FDA Pre-Market Approval
FDA Class 3 ·MiSeqDx Extended RAS Panel