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.
O&M Halyard, Inc. - FDA 510(k) Cleared Devices
Recent clearances: HALYARD* ONE-STEP* Sterilization Wrap, HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
24
Total
24
Cleared
0
Denied
O&M Halyard, Inc. has 24 FDA 510(k) cleared general hospital devices. Based in Alpharetta, US.
Latest FDA clearance: May 2026. 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) Regulatory Record - O&M Halyard, Inc.
24 devices
Cleared
May 18, 2026
HALYARD* ONE-STEP* Sterilization Wrap
General Hospital
227d
Cleared
Mar 18, 2026
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO...
General Hospital
265d
Cleared
Dec 11, 2025
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
General Hospital
87d
Cleared
Aug 18, 2025
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis...
General Hospital
270d
Cleared
Jun 18, 2025
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs
General Hospital
261d
Cleared
Dec 17, 2024
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology,...
General Hospital
111d
Cleared
Sep 27, 2024
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential,...
General Hospital
88d
Cleared
Sep 16, 2024
HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization...
General Hospital
270d
Cleared
Aug 07, 2024
HALYARD* SMART-FOLD* Sterilization Wrap (H450)
General Hospital
184d
Cleared
Mar 22, 2024
Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential,...
General Hospital
266d
Cleared
Aug 16, 2022
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves...
General Hospital
243d
Cleared
Aug 01, 2022
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with...
General Hospital
228d