180 results
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24ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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INNOVANCE D-DIMER, MODEL OPBP09
FDA 510(k)
FDA Class 2
·Hematology
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PROTEIN S AC
FDA 510(k)
FDA Class 2
·Hematology
EMIT 2000 VANCOMYCIN CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LOCI 8 CALIBRATOR, MODEL KC 646
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STRATUS CS ACUTE CARE D-DIMER
FDA 510(k)
FDA Class 2
·Hematology
oCare Wrist Pulse Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST
FDA 510(k)
FDA Class 2
·Immunology
DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
FDA 510(k)
FDA Class 2
·Immunology
PT-MULTI-CALIBRATOR, MODEL OPAT07
FDA 510(k)
FDA Class 2
·Hematology
POWERED WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
ORTHOFAB WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
ONTRAK TESTCUP PRO-5, MODEL 1986678
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CUTTER RESIFLEX FOLEY CATHETERS
FDA 510(k)
FDA Class 2
·Clinical Toxicology