FDA applicant
Terumo (Philippines) Corporation
FDA records 5 decisions for Terumo (Philippines) Corporation (Elkton, MD) from 2012 to 2015: 5 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 7 predicates, 2 of them its own earlier devices. 9 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Terumo (Philippines) Corporation’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
9in 2019
Class I Class II/III not classified
Planning a device like Terumo (Philippines) Corporation’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.