FDA applicant
Takiron Co., Ltd.
FDA records 6 decisions for Takiron Co., Ltd. (Chuo-Ku, Kobe, Hyogo, JP) from 2007 to 2008: 6 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HTY (Pin, Fixation, Smooth). Its devices cite 26 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Takiron Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2008
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Takiron Co., Ltd.’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) Report