FDA applicant
Terumo America, Inc.
FDA records 31 decisions for Terumo America, Inc. (Mchenry, IL) from 1976 to 1981: 31 510(k) clearances. Most are in product codes FJI (Dialyzer, Capillary, Hollow Fiber) and FMI (Needle, Hypodermic, Single Lumen). 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Terumo America, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Terumo America, Inc. since 2007.
Recalls per year
1in 2010
Class I Class II/III not classified
Planning a device like Terumo America, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Terumo”
FDA records each applicant name separately; these may or may not be the same firm.