288 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72
FDA 510(k)
FDA Class 2
·Hematology
The Multimodality Advanced Vessel Analysis
FDA 510(k)
FDA Class 2
·Radiology
KODEX EPD System
FDA 510(k)
FDA Class 2
·Cardiovascular
EAR THERMOMETER, MODEL WL-320X
FDA 510(k)
FDA Class 2
·General Hospital
BLOOD PRESSURE MONITOR, MODEL M100
FDA 510(k)
FDA Class 2
·Cardiovascular
DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306
FDA 510(k)
FDA Class 2
·General Hospital
Access PCT
FDA 510(k)
FDA Class 2
·Microbiology
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set
FDA 510(k)
FDA Class 2
·Microbiology
DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls
FDA 510(k)
FDA Class 2
·Microbiology
Access PCT, Access PCT Calibrators
FDA 510(k)
FDA Class 2
·Microbiology
Lung Nodule Assessment and Comparison Option (LNA)
FDA 510(k)
FDA Class 2
·Radiology
LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub
FDA 510(k)
FDA Class 2
·Cardiovascular
XPERCT REL. 3
FDA 510(k)
FDA Class 2
·Radiology
Ingenia Elition and MR 7700 MR Systems
FDA 510(k)
FDA Class 2
·Radiology
Philips IntelliSite Pathology Solution 5.1
FDA 510(k)
FDA Class 2
·Pathology
Brain Perfusion (BP) application
FDA 510(k)
FDA Class 2
·Radiology
16 Breast Coil
FDA 510(k)
FDA Class 2
·Radiology
Philips IntelliSite Pathology Solution
FDA 510(k)
FDA Class 2
·Pathology
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
FDA 510(k)
FDA Class 2
·Radiology