Medical Device Manufacturer · US , Mechanicsville , VA

Owens & Minor (O&M) Halyard, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2019
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.

FDA 510(k) cleared devices by Owens & Minor (O&M) Halyard, Inc.

12 devices
1-12 of 12
Cleared May 30, 2025
Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804)
K243010 · FXX
General Hospital · 246d
Cleared Jul 02, 2024
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT*...
K232824 · FXX
General Hospital · 293d
Cleared Jul 01, 2024
FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops,...
K232777 · FXX
General Hospital · 294d
Cleared Jun 21, 2024
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869)
K232807 · FXX
General Hospital · 283d
Cleared Jun 14, 2024
Fluidshield* 2 Fog-Free Surgical Mask (62113)
K232812 · FXX
General Hospital · 276d
Cleared Jun 07, 2024
HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft...
K232806 · FXX
General Hospital · 269d
Cleared Jun 04, 2024
HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
K232820 · FXX
General Hospital · 265d
Cleared May 16, 2024
Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer...
K232849 · FYC
General Hospital · 245d
Cleared Jan 12, 2024
Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask...
K233022 · MSH
General Hospital · 112d
Cleared Jan 08, 2024
HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT*...
K232894 · FXX
General Hospital · 112d
Cleared Jul 27, 2022
HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap
K214007 · FRG
General Hospital · 217d
Cleared Oct 10, 2019
Halyard ONE-STEP* Sterilization Wrap
K192147 · FRG
General Hospital · 63d
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