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Terumo America, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
31
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K811523PLASMA FLEXSeptember 9, 1981
K802970TERUMO HOLLOW FIBER OXYGENATORJanuary 22, 1981
K802441CLIRANS TH10 HOLLOW FIBER DIALYZERDecember 18, 1980
K802122CLIRANS TH13 HOLLOW FIBER DIALYZERDecember 18, 1980
K801192CLIRANS TE10 HOLLOW FIBER DIALYZERAugust 12, 1980
K801194CLIRANS TE07 HOLLOW FIBER DIALYZERAugust 12, 1980
K801193CLIRANS TE15 HOLLOW FIBER DIALYZERAugust 12, 1980
K791411COAXIAL DUAL FLOW CATHETERNovember 13, 1979
K791173SURFLO INJECTION PLUGJuly 30, 1979
K790105TERUMO IMUGARDMay 24, 1979
K772362AVF SET FOR SINGLE NEEDLE HEMODIALYSISMarch 17, 1978
K772040TRANSDUCER PROTECTORNovember 28, 1977
K771432HICALIQ IVH BAGSeptember 28, 1977
K771431ARTIFICIAL K-NOSE BREATHAIDSeptember 28, 1977
K771693CLIRANS BLOOD LINES SETSeptember 20, 1977
K771430BLOOD FILTER, W/SETSeptember 20, 1977
K771694CLIRANS TH 15 HOLLOW FIBER DIALYZERSeptember 15, 1977
K771212SAFEED DISP. PLASTIC CATHETERSeptember 12, 1977
K771458INFUSION ACCELERATORAugust 26, 1977
K771454MICRO SYRINGE & NEEDLEAugust 16, 1977