27 results
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46ms
·
Sources: EU EUDAMED, US FDA
SYNGO, CT BONE READING
FDA registration
Siemens Healthineers AG·1 product·🇩🇪 Germany
Elecsys CA 125 II Assay
FDA registration
ROCHE DIAGNOSTICS GMBH·2 products·🇩🇪 Germany
Synergy Health Ireland Ltd
FDA registration
Synergy Health Ireland Ltd·1 product·🇮🇪 Ireland
LIQUICHEK BNP CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS
FDA 510(k)
FDA Class 2
·Cardiovascular
Single (Specified) Analyte Controls (Assayed And Unassayed)
FDA classification
FDA Class 1
·Single (Specified) Analyte Controls (Assayed And Unassayed)
Oximeter
FDA classification
FDA Class 2
·Oximeter