510(k) K051291 ยท FXX Mask, Surgical
NON-STERILE SURGICAL MASK
| Applicant | A.R. Medicom, Inc., Lachine (Montreal), CA |
| Decision | Substantially Equivalent, Sep 20, 2005 |
| Received | May 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051291
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2024 | AMD Medicom Inc. HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448) Open, Classified |
FXX | None listed |
| Feb 16, 2024 | AMD Medicom Inc. HENRY SCHEIN CRITERION ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281) Open, Classified |
FXX | None listed |
| Feb 16, 2024 | AMD Medicom Inc. PATTERSON PROCEDURE EARLOOP MASKS- ANTI-FOG, ASTM LEVEL 3 (BLUE) (item code 127-7573) Open, Classified |
FXX | None listed |
| Oct 11, 2019 | AMD Medicom Inc. MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040 Terminated |
FXX | None listed |
| Oct 11, 2019 | AMD Medicom Inc. MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042 Terminated |
FXX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.