Medical Device Manufacturer · US , Alpharetta , GA

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

23 submissions · 23 cleared · Since 2019
23
Total
23
Cleared
0
Denied

O&M Halyard, Inc. has 23 FDA 510(k) cleared general hospital devices. Based in Alpharetta, US.

Latest FDA clearance: Mar 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) cleared devices by O&M Halyard, Inc.

23 devices
1-12 of 23
Cleared Mar 18, 2026
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO...
K251967 · FXX
General Hospital · 265d
Cleared Dec 11, 2025
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
K252941 · FXX
General Hospital · 87d
Cleared Aug 18, 2025
Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis...
K243604 · LZA
General Hospital · 270d
Cleared Jun 18, 2025
Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs
K243172 · LZA
General Hospital · 261d
Cleared Dec 17, 2024
Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology,...
K242558 · LZA
General Hospital · 111d
Cleared Sep 27, 2024
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential,...
K241909 · LZA
General Hospital · 88d
Cleared Sep 16, 2024
HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization...
K234050 · FRG
General Hospital · 270d
Cleared Aug 07, 2024
HALYARD* SMART-FOLD* Sterilization Wrap (H450)
K240330 · FRG
General Hospital · 184d
Cleared Mar 22, 2024
Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential,...
K231938 · LZA
General Hospital · 266d
Cleared Aug 16, 2022
Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves...
K213937 · LZA
General Hospital · 243d
Cleared Aug 01, 2022
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with...
K213929 · LZA
General Hospital · 228d
Cleared Jun 02, 2022
PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile...
K220541 · LZA
General Hospital · 97d
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