FDA 510(k) Applications Submitted by Owens & Minor (O&M) Halyard, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K243010 |
09/26/2024 |
Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with S |
Owens & Minor (O&M) Halyard, Inc. |
| K232807 |
09/12/2023 |
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802) |
Owens & Minor (O&M) Halyard, Inc. |
| K232812 |
09/12/2023 |
Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62 |
Owens & Minor (O&M) Halyard, Inc. |
| K232806 |
09/12/2023 |
HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) |
Owens & Minor (O&M) Halyard, Inc. |
| K232820 |
09/13/2023 |
HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) |
Owens & Minor (O&M) Halyard, Inc. |
| K232894 |
09/18/2023 |
HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) |
Owens & Minor (O&M) Halyard, Inc. |
| K233022 |
09/22/2023 |
Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Sm |
Owens & Minor (O&M) Halyard, Inc. |
| K214007 |
12/22/2021 |
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap |
Owens & Minor (O&M) Halyard, Inc. |
| K232777 |
09/11/2023 |
FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) |
Owens & Minor (O&M) Halyard, Inc. |
| K232824 |
09/13/2023 |
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOF |
Owens & Minor (O&M) Halyard, Inc. |
| K232849 |
09/14/2023 |
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. |
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