FDA applicant
Synovis Life Technologies, Inc.
FDA records 9 decisions for Synovis Life Technologies, Inc. (St. Paul, MN) from 2013 to 2023: 9 510(k) clearances. Most are in product codes MVR (Device, Anastomotic, Microvascular) and DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe…). Its devices cite 13 predicates, 4 of them its own earlier devices. 15 recalls are linked to its devices, 1 Class I.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Synovis Life Technologies, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
3in 2024
Class I Class II/III not classified
Planning a device like Synovis Life Technologies, Inc.’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.