Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Norwood Abbey , Ltd. · 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) |
|---|---|---|---|---|---|
| K051486 | NORWOOD ABBEY CENTURION SES EPIKERATOME | Norwood Abbey , Ltd. | 2005-07-06 | 30 | 0 |
| K042810 | CENTURION SES EPIKERATOME | Norwood Abbey , Ltd. | 2004-10-28 | 16 | 0 |
| K033962 | LAD (EPITURE EASYTOUCH), MODEL LAD-08 | Norwood Abbey , Ltd. | 2004-02-20 | 60 | 0 |
| K021222 | LAD, MODEL LAD-01 | Norwood Abbey , Ltd. | 2003-01-08 | 266 | 0 |
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