FDA applicant
Syntec Scientific Corp.
FDA records 19 decisions for Syntec Scientific Corp. (Chang Hua, TW) from 1998 to 2021: 19 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 330 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 10 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Syntec Scientific Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Syntec Scientific Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Syntec Scientific Corp.’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 “Syntec”
FDA records each applicant name separately; these may or may not be the same firm.