FDA applicant
Apatech, Ltd.
FDA records 8 decisions for Apatech, Ltd. (Oregon City, OR) from 2004 to 2009: 8 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and LYC (Bone Grafting Material, Synthetic). Its devices cite 16 predicates, 9 of them its own earlier devices. 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 Apatech, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2009
2026 so far, outlined.
Recalls per year
1in 2015
Class I Class II/III not classified
Planning a device like Apatech, 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