Home › AMD Medicom Inc › Medicom SafeMask
Medicom SafeMask
AMD Medicom Inc · Model 203214 · UDI-DI 10686864056901
10
510(k) clearances
194
Adverse events
3
Recalls
226
Facilities
Description
Medicom Safemask ArchitectPro - Surgical/N95 Respirator - White - Small
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-09 | O&M HALYARD, INC. | One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user. |
| 2008-07-23 | Inovel LLC | Display boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators. |
| 2006-02-20 | Inovel LLC | Mislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect mod |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.