4,842 results · 50ms · Sources: EU EUDAMED, US FDA

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval
FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval
FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval
FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval
FDA Class 3 ·VENTANA ALK (D5F3) CDX ASSAY

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval
FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

Dimension Vista® PROG Calibrator

FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414948768·Progesterone Calibrator, 10 (2A x 1.0 mL; 2B x ...

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·IntellaNav XP, Nav MiFi XP

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MMR RxDx Panel

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MMR RxDx Panel

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA Pre-Market Approval
FDA Class 3 ·VENTANA MMR RxDx Panel

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·IntellaNav Ol

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL and Verity ADx XL

Programmer, Pacemaker

FDA Pre-Market Approval
FDA Class 3 ·VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·VERITY ADX XL VDR MODEL 5456I PULSE GENERATOR

Dimension Vista® LOCI 4 CAL

FDA UDI
Siemens Healthcare Diagnostics Inc.·00842768033827·LOCI 4 Calibrator, 10 (2A x 2.0 mL; 2B x 2.0 mL...

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·LeukoStrat® CDx FL T3 Mutation Assay

ON THE SPOT CANDIDASURE

FDA 510(k)
FDA Class 2 ·Microbiology

CANDIDATE(R) SUPER

FDA 510(k)
FDA Class 2 ·Microbiology

EI-CANDIDA ENZYME IMMUNOASSAY EI1001

FDA 510(k)
FDA Class 2 ·Microbiology