Halyard Health (Owens & Minor Halyard)
Surgical and infection prevention products for healthcare providers worldwide.
Halyard Health (now part of Owens & Minor) is a manufacturer of medical supplies focused on surgical and infection prevention products including NIOSH-approved respirators, surgical masks, sterilization wraps, facial protection, and medical drapes. The company's S&IP segment serves acute care hospitals, ambulatory surgery centers, and long-term care facilities with disposable protective apparel and infection prevention consumables. Halyard's pain management portfolio includes ON-Q and ambIT continuous peripheral nerve block infusion systems for post-surgical pain control.
- Type
- Manufacturer
- Location
- Alpharetta, GA, United States
- Founded
- 2014
- Website
- halyardhealth.com
- Categories
- Medical & Healthcare Supplies, Safety & Protective Equipment
- Markets
- United States, Canada, United Kingdom, Germany, Australia, Japan
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-08 Mail server of the company domain
- debarment-clear (green), checked 2026-08-08 OpenSanctions
- sanctions-clear (green), checked 2026-08-08 OpenSanctions
- domain-registered (green), checked 2026-08-08 Domain registry record
Claimed certifications
- ISO 13485, Medical Devices Quality IAF CertSearch
- ISO 9001, Quality Management IAF CertSearch
- FDA Registered FDA Establishment Registration
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
- Protective equipment (helmets, gloves, eyewear) sold in the EU falls under the PPE Regulation (EU) 2016/425 and needs CE marking. European Commission (PPE)