361 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
×
IMMULITE® 2000 Cortisol
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FilmArray Pneumonia Panel plus
FDA 510(k)
FDA Class 2
·Pathology
BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
FDA 510(k)
FDA Class 2
·Pathology
FilmArray Pneumonia Panel plus
FDA 510(k)
FDA Class 2
·Pathology
IMPRESARIO
FDA 510(k)
FDA Class 2
·Cardiovascular
VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ARIA
FDA 510(k)
FDA Class 2
·Cardiovascular
LIFESCREEN APNEA
FDA 510(k)
FDA Class 2
·Anesthesiology
SENTINEL
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIONAVIGATOR +
FDA 510(k)
FDA Class 2
·Cardiovascular
FIGURETRIM
FDA 510(k)
FDA Class 2
·Physical Medicine
VOYAGER 12
FDA 510(k)
FDA Class 2
·Cardiovascular
HRV TOOLS
FDA 510(k)
FDA Class 2
·Cardiovascular
AERO-MIST NEBULIZER HEATER
FDA 510(k)
FDA Class 2
·Anesthesiology
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
FDA 510(k)
FDA Class 2
·Medical Genetics
Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems
FDA 510(k)
FDA Class 2
·Medical Genetics
Quantidex qPCR BCR-ABL IS Kit
FDA 510(k)
FDA Class 2
·Medical Genetics
ipsogen JAK2 RGQ PCR Kit
FDA 510(k)
FDA Class 2
·Medical Genetics
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports
FDA 510(k)
FDA Class 2
·Medical Genetics
QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
FDA 510(k)
FDA Class 2
·Medical Genetics