Owens & Minor (O&M) Halyard, Inc.
United StatesFDA applicant, unverified
- Devices
- 14
What Owens & Minor (O&M) Halyard, Inc. makes
The company manufactures single-use surgical and procedure masks, including fog-free variants with soft linings and optional visors, as well as N95 particulate filter respirators combined with surgical masks. It also produces sterilization wraps for medical instruments and tri-layer isolation gowns meeting AAMI Level 3 standards.
These products are classified as Class II medical devices and are listed via FDA 510(k) submissions. The manufacturer is based in the United States.
Catalogue
Search and filter all 14 devicesFrequently asked questions
How many devices does Owens & Minor (O&M) Halyard, Inc. have in the registry?
The registry currently lists 14 devices for Owens & Minor (O&M) Halyard, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Owens & Minor (O&M) Halyard, Inc.'s devices?
Among its 14 most recently registered devices, Owens & Minor (O&M) Halyard, Inc. has devices listed in FDA 510(k) (14 devices).
What risk classes do Owens & Minor (O&M) Halyard, Inc.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Owens & Minor (O&M) Halyard, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Owens & Minor (O&M) Halyard, Inc. in the registry?
The most recently registered devices listed for Owens & Minor (O&M) Halyard, Inc. include HALYARD SMART-FOLD* Sterilization Wrap (H450, H650), HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806), Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs and HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap.