382 results
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25ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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DOCUMENT CK ISOENZYMES CONTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPIROMETRICS MODEL 2600 MIRO SPIROMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
BinaxNOW COVID-19 Ag Card
FDA 510(k)
FDA Class 2
·Microbiology
WAYPOINT STEREOTACTIC SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
FilmArray RP2/RP2plus Control Panel
FDA 510(k)
FDA Class 2
·Microbiology
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M
FDA 510(k)
FDA Class 2
·Immunology
DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
FDA 510(k)
FDA Class 2
·Microbiology
ALERE I INFLUENZA A & B
FDA 510(k)
FDA Class 2
·Microbiology
ACTIVEECG
FDA 510(k)
FDA Class 2
·Cardiovascular
FLOWMATE LTE
FDA 510(k)
FDA Class 2
·Anesthesiology
CLEARVIEW EXACT II INFLUENZA A & B TEST
FDA 510(k)
FDA Class 2
·Microbiology
TURBO-RAST SPECIFIC IGE ASSAY
FDA 510(k)
FDA Class 2
·Immunology
CONTEMPRO-MIST
FDA 510(k)
FDA Class 2
·Anesthesiology
MICROLAB SPIROMETER
FDA 510(k)
FDA Class 2
·Anesthesiology
VENTREX COATED TUBE HIGH SENSITIVITY TSH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VISIONLINK DICOM MODULE
FDA 510(k)
FDA Class 2
·Radiology
Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit
FDA 510(k)
FDA Class 2
·Microbiology
VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM.
FDA 510(k)
FDA Class 2
·Immunology