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

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

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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