Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Maersk Medical, 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) |
|---|---|---|---|---|---|
| K004028 | ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING | Maersk Medical, Ltd. | 2001-03-27 | 90 | 0 |
| K990810 | ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRES | Maersk Medical, Ltd. | 1999-09-17 | 190 | 0 |
| K973657 | ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING | Maersk Medical, Ltd. | 1997-12-01 | 67 | 0 |
| K970566 | ARGLAES FILM DRESSING | Maersk Medical, Ltd. | 1997-07-29 | 166 | 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