Owens & Minor (O&M) Halyard, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243010 | Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Sur | May 30, 2025 |
| K232824 | FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FL | July 2, 2024 |
| K232777 | FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHI | July 1, 2024 |
| K232807 | Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surg | June 21, 2024 |
| K232812 | Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound | June 14, 2024 |
| K232806 | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Le | June 7, 2024 |
| K232820 | HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) | June 4, 2024 |
| K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X | May 16, 2024 |
| K233022 | Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orang | January 12, 2024 |
| K232894 | HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* F | January 8, 2024 |
| K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap | July 27, 2022 |
| K192147 | Halyard ONE-STEP* Sterilization Wrap | October 10, 2019 |