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

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

23 devices
1-23 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
Cleared Jun 02, 2022
PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile...
K220547 · LZA
General Hospital · 97d
Cleared Jan 02, 2022
Sterisystem Dry-Base Instrument Tray
K203177 · KCT
General Hospital · 433d
Cleared Nov 19, 2021
HALYARD Flexaprene Green Powder-Free Exam Glove
K211063 · LZA
General Hospital · 224d
Cleared Jul 21, 2021
AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line...
K210688 · FYA
General Hospital · 135d
Cleared Jan 07, 2021
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested...
K202622 · LZA
General Hospital · 119d
Cleared Sep 22, 2020
Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with...
K200843 · LZA
General Hospital · 175d
Cleared Mar 16, 2020
AERO CHROME* Breathable Performance Surgical Gowns
K200522 · FYA
General Hospital · 14d
Cleared Dec 13, 2019
Aero Blue Performance Surgical Gowns
K192362 · FYA
General Hospital · 105d
Cleared Nov 08, 2019
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG*...
K191230 · LZC
General Hospital · 184d
Cleared Jun 26, 2019
SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with...
K182851 · LZA
General Hospital · 259d
Cleared Feb 05, 2019
Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with...
K183132 · LZC
General Hospital · 84d
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