438 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
FDA 510(k)
FDA Class 2
·Microbiology
MODIFICATION TO M2376A DEVICELINK SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
M2376A DEVICELINK SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
M2376A DEVICELINK SYSTEM, MODEL M2376A
FDA 510(k)
FDA Class 2
·Cardiovascular
DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426
FDA 510(k)
FDA Class 2
·Immunology
HP M2600A VIRIDIA TELEMETRY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
MrOpen
FDA 510(k)
FDA Class 2
·Radiology
FIBRINOGEN CALIBRATOR KIT
FDA 510(k)
FDA Class 2
·Hematology
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O
FDA 510(k)
FDA Class 2
·Cardiovascular
DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
FDA 510(k)
FDA Class 2
·Clinical Chemistry
M2376A DEVICELINK SYSTEM, MODEL M2376A
FDA 510(k)
FDA Class 2
·Cardiovascular
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/H5 SUBTYPING
FDA 510(k)
FDA Class 2
·Microbiology
DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
FDA 510(k)
FDA Class 2
·Immunology
LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
FDA 510(k)
FDA Class 2
·Immunology