FDA applicant
Synovis Orthopedic & Woundcare
FDA records 3 decisions for Synovis Orthopedic & Woundcare (Irvine, CA) from 2011 to 2012: 3 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and KGN (Wound Dressing With Animal-Derived Material (S)). Its devices cite 15 predicates, 0 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 Synovis Orthopedic & Woundcare’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Synovis Orthopedic & Woundcare’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 “Synovis”
FDA records each applicant name separately; these may or may not be the same firm.