2,418 results · 46ms · Sources: EU EUDAMED, US FDA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·AFFINITY/ENTITY/IDENTITY ADX/INTREGRITY/INTEGRITY MICRO/VERITY ADX PACEMAKERS

Reveal

FDA registration
AMERICAN SCREENING CORPORATION·4 products·🇺🇸 United States

CardioChek Home Chol+HDL+GLU Test Strip

FDA registration
Polymer Technology Systems·4 products·🇺🇸 United States

HDL Cholesterol Reagent Kit

FDA registration
JAS Diagnostics/Drew Scientific·3 products·🇺🇸 United States

cardiochek Plus Test System, Cardiochek Home Test System

FDA registration
East West Wisconsin·4 products·🇺🇸 United States

STANDARD LipidoCare Home System

FDA registration
SD BIOSENSOR, INC.·4 products·🇰🇷 South Korea

Sekisui Diagnostics P.E.I. Inc.

FDA registration
Sekisui Diagnostics P.E.I. Inc.·3 products·🇨🇦 Canada

STANDARD LipidoCare Home System

FDA registration
SD Biosensor, Inc.·4 products·🇰🇷 South Korea

CardioChek PA

FDA registration
Polymer Technology Systems·4 products·🇺🇸 United States

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne CDx Assay

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACANALYSIS CDX DEVICE

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACAnalysis CDx Device

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

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

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

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

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

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

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

FDA Pre-Market Approval
FDA Class 3 ·FoundationOne Liquid CDx

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·ADX PULSE GENERATOR

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

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

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·BRACAnalysis CDx®