Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terumo America, Inc.

FDA 510(k) & PMA Approved Devices — 31 products

Total Devices31
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K811523 PLASMA FLEXKSR1981-09-09 View
510(k) K802970 TERUMO HOLLOW FIBER OXYGENATORDTZ1981-01-22 View
510(k) K802441 CLIRANS TH10 HOLLOW FIBER DIALYZERFJI1980-12-18 View
510(k) K802122 CLIRANS TH13 HOLLOW FIBER DIALYZERFJI1980-12-18 View
510(k) K801193 CLIRANS TE15 HOLLOW FIBER DIALYZERKDJ1980-08-12 View
510(k) K801192 CLIRANS TE10 HOLLOW FIBER DIALYZERFJI1980-08-12 View
510(k) K801194 CLIRANS TE07 HOLLOW FIBER DIALYZERFJI1980-08-12 View
510(k) K791411 COAXIAL DUAL FLOW CATHETERKOC1979-11-13 View
510(k) K791173 SURFLO INJECTION PLUGFPA1979-07-30 View
510(k) K790105 TERUMO IMUGARDGKT1979-05-24 View
510(k) K772362 AVF SET FOR SINGLE NEEDLE HEMODIALYSISFIE1978-03-17 View
510(k) K772040 TRANSDUCER PROTECTORFKJ1977-11-28 View
510(k) K771432 HICALIQ IVH BAGKPE1977-09-28 View
510(k) K771431 ARTIFICIAL K-NOSE BREATHAID1977-09-28 View
510(k) K771430 BLOOD FILTER, W/SETFPB1977-09-20 View
510(k) K771693 CLIRANS BLOOD LINES SETFJK1977-09-20 View
510(k) K771694 CLIRANS TH 15 HOLLOW FIBER DIALYZERFJI1977-09-15 View
510(k) K771212 SAFEED DISP. PLASTIC CATHETERKNY1977-09-12 View
510(k) K771458 INFUSION ACCELERATORKZD1977-08-26 View
510(k) K771454 MICRO SYRINGE & NEEDLE1977-08-16 View
↑