150 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P
FDA 510(k)
FDA Class 2
·Hematology
ENZYMATIC CO2 REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ETHANOL CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DURAZYME(R) CPK
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KINETIC 610 ETHANOL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACU-TRAIN V (5)
FDA 510(k)
FDA Class 2
·Physical Medicine
DIRECT ACU-SLIDE TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Acu-Sinch Knotless Mini
FDA 510(k)
FDA Class 2
·Orthopedic
MONO ACU-SLIDE TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACU-DERM TRANSPARENT INCISE DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACU-STIM TENS, AP-101082T
FDA 510(k)
FDA Class 2
·Neurology
ACU-CUT VERTEBRAL AUGMENTATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACU-PREG-AL SLIDE TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ACU-SYRINGE W/WO NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
FDA 510(k)
FDA Class 2
·Immunology
ACU-TEST IN-HOME PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
KEELER ACU 22XT OPHTHALMIC CRYO UNIT
FDA 510(k)
FDA Class 2
·Ophthalmic