Owens & Minor (O&M) Halyard, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Owens & Minor (O&M) Halyard, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804), FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802), FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868)
12
Total
12
Cleared
0
Denied
Owens & Minor (O&M) Halyard, Inc. has 12 FDA 510(k) cleared general hospital devices. Based in Mechanicsville, US.
Latest FDA clearance: May 2025. Active since 2019.
Browse the complete list of FDA 510(k) cleared general hospital devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Peter R Kalkbrenner Sterilucent, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Owens & Minor (O&M) Halyard, Inc.
12 devices
Cleared
May 30, 2025
Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)
General Hospital
246d
Cleared
Jul 02, 2024
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*...
General Hospital
293d
Cleared
Jul 01, 2024
FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops,...
General Hospital
294d
Cleared
Jun 21, 2024
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869)
General Hospital
283d
Cleared
Jun 14, 2024
Fluidshield* 2 Fog-Free Surgical Mask (62113)
General Hospital
276d
Cleared
Jun 07, 2024
HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft...
General Hospital
269d
Cleared
Jun 04, 2024
HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
General Hospital
265d
Cleared
May 16, 2024
Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer...
General Hospital
245d
Cleared
Jan 12, 2024
Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask...
General Hospital
112d
Cleared
Jan 08, 2024
HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT*...
General Hospital
112d
Cleared
Jul 27, 2022
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
General Hospital
217d
Cleared
Oct 10, 2019
Halyard ONE-STEP* Sterilization Wrap
General Hospital
63d