502 results · 29ms · Sources: EU EUDAMED, US FDA

uMI 780 PET/CT System

FDA 510(k)
FDA Class 2 ·Radiology

Medical Image Post-processing Software (uOmnispace.CT)

FDA 510(k)
FDA Class 2 ·Radiology

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT HAVAB/HAVAB EIA/IMX HAVAB

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT HAVAB/HAVAB EIA/IMX HAVAB

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT COMMANDER(R) PPC AFP-EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA

ST AIA-PACK C-PEPTIDE II CALIBRATOR SET

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CYFRA 21-1 EIA MODEL 211-10

FDA 510(k)
FDA Class 2 ·Immunology

Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker

FDA 510(k)
FDA Class 2 ·Immunology

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR NTDS

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER

uPMR 790

FDA 510(k)
FDA Class 2 ·Radiology

uMR 580, uMR 588

FDA 510(k)
FDA Class 2 ·Radiology

uCT Computed Tomography X-ray System

FDA 510(k)
FDA Class 2 ·Radiology

uCT ATLAS with uWS-CT-Dual Energy Analysis

FDA 510(k)
FDA Class 2 ·Radiology

uMR 560

FDA 510(k)
FDA Class 2 ·Radiology