Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Synovis Micro Companies Alliance, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221843 | GEM Biover Microvascular Clamps | Synovis Micro Companies Alliance, Inc. | 2022-09-14 | 82 | 0 |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2) | Synovis Micro Companies Alliance, Inc. | 2022-04-20 | 121 | 0 |
| K093310 | GEM FLOW COUPLER DEVICE AND SYSTEM | Synovis Micro Companies Alliance, Inc. | 2010-02-01 | 102 | 0 |
| K040163 | MICROVASCULAR ANASTOMOTIC DEVICE | Synovis Micro Companies Alliance, Inc. | 2004-04-16 | 81 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda