Company ยท US
Owens & Minor (O&M) Halyard, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2025. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 30, 2025 | K243010 | Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO S Owens & Minor (O&M) Halyard, Inc. | FXX |
| Jul 2, 2024 | K232824 | FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Fre Owens & Minor (O&M) Halyard, Inc. | FXX |
| Jul 1, 2024 | K232777 | FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Proce Owens & Minor (O&M) Halyard, Inc. | FXX |
| Jun 21, 2024 | K232807 | Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SO Owens & Minor (O&M) Halyard, Inc. | FXX |
| Jun 14, 2024 | K232812 | Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Flui Owens & Minor (O&M) Halyard, Inc. | FXX |
| Jun 7, 2024 | K232806 | HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask Owens & Minor (O&M) Halyard, Inc. | FXX |
| Jun 4, 2024 | K232820 | HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) Owens & Minor (O&M) Halyard, Inc. | FXX |
| May 16, 2024 | K232849 | Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) Owens & Minor (O&M) Halyard, Inc. | FYC |
| Jan 12, 2024 | K233022 | Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small Owens & Minor (O&M) Halyard, Inc. | MSH |
| Jan 8, 2024 | K232894 | HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgic Owens & Minor (O&M) Halyard, Inc. | FXX |
| Jul 27, 2022 | K214007 | HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap Owens & Minor (O&M) Halyard, Inc. | FRG |
| Oct 10, 2019 | K192147 | Halyard ONE-STEP* Sterilization Wrap Owens & Minor (O&M) Halyard, Inc. | FRG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||