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
26
Total
26
Cleared
0
Denied
FDA 510(k) Regulatory Record - O&M Halyard, Inc. General Hospital ✕
26 devices
Cleared
Jul 21, 2026
PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves
General Hospital
36d
Cleared
Jul 02, 2026
HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology
General Hospital
27d
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