FDA applicant
Remex Medical Corp.
FDA records 7 decisions for Remex Medical Corp. (Taichung, TW) from 2022 to 2026: 7 510(k) clearances. All are in product code OLO (Orthopedic Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 9 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Remex Medical Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Remex Medical Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Remex Medical 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) Report