275 results · 42ms · Sources: EU EUDAMED, US FDA

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECONDLOOK COMPUTER-AIDED DETECTION SYSTEM

CANDIDA DETECTION SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

PLAQUE DETECTION SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM

CARDIOX FLOW DETECTION SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

Halo AF Detection System

FDA 510(k)
FDA Class 2 ·Cardiovascular

SARNS AIR DETECTION SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

JBAIDS ANTHRAC DETECTION SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

MULTI-ANALYTE DETECTION SYSTEMS

FDA 510(k)
FDA Class 2 ·Immunology

VOLMETRIC COINCIDENCE DETECTION SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECOND LOOK COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

Parathyroid Detection (Model PTeye) System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS

FDA 510(k)
FDA Class 2 ·Microbiology

Analyzer, Medical Image

FDA Pre-Market Approval
FDA Class 2 ·SECOND LOOK ANALOG 6.0 COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM

FDA 510(k)
FDA Class 2 ·Microbiology

A1AT Genotyping Test

FDA 510(k)
FDA Class 2 ·Immunology