Owens & Minor (O&M) Halyard, Inc.
Owens & Minor (O&M) Halyard, Inc. has 0 FDA recalls, 0 inspections, 12 510(k) clearances and 0 compliance actions on record.
- Latest 510(k)
- May 30, 2025
Reviewing Owens & Minor (O&M) Halyard, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or get Owens & Minor (O&M) Halyard, Inc.'s full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 12 | Oct 4, 2026 | Not stated | Current |
| Inspections | 0 | Oct 25, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|---|---|---|---|---|
| Owens | 0 | 0 | 0 | 3 | — |
| Owens And Minor Distribution, Inc. Om20 | 0 | 0 | 2 | 0 | — |
| Owens And Minor Halyard | 0 | 2 | 0 | 0 | — |
| Owens And Minor/Halyard | 0 | 0 | 2 | 0 | — |
| Owens And Minor Distribution Center 49 | 0 | 0 | 1 | 0 | — |
| Owens And Minor Distribution Inc. Om45 | 0 | 0 | 1 | 0 | — |
| Owens And Minor Distribution Om70 | 0 | 0 | 1 | 0 | — |
| Owens And Minor Distribution Om77 | 0 | 0 | 1 | 0 | — |
| Owens And Minor Distribution Om94 | 0 | 0 | 1 | 0 | — |
| Owens Roots And Herbs | 0 | 0 | 1 | 0 | — |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K243010 | Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3… | May 30, 2025 |
| K232824 | FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802)… | Jul 2, 2024 |
| K232777 | FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868)… | Jul 1, 2024 |
| K232807 | Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1… | Jun 21, 2024 |
| K232812 | Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound… | Jun 14, 2024 |
| K232806 | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD*… | Jun 7, 2024 |
| K232820 | HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) | Jun 4, 2024 |
| K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown… | May 16, 2024 |
| K233022 | Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining… | Jan 12, 2024 |
| K232894 | HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD*… | Jan 8, 2024 |
| K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap | Jul 27, 2022 |
| K192147 | Halyard ONE-STEP* Sterilization Wrap | Oct 10, 2019 |