# O&M Halyard, Inc. (manufacturer, Alpharetta, GA): 11 new FDA device listings, incl. wrap, sterilization

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | O&M Halyard, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device; Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198; Repack or Relabel Medical Device |
| Location | Alpharetta, GA, US |
| New listings | 11 |
| Devices | Wrap, Sterilization; Anti Fog Solution And Accessories, Endoscopy; Clinical Electronic Thermometer; Restraint, Protective; Dressing, Wound, Drug; Fentanyl And Other Opioid Protection Glove; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Medical Glove, Specialty; Polymer Patient Examination Glove; Orthosis, Limb Brace |
| Product codes | FRG, OCT, SDV, FMQ, FRO, QDO, OPJ, LZC, LZA, IQI |
| Device classes | Class I, Class II, Unclassified |
| Medical specialties | General Hospital, Gastroenterology, Urology, Physical Medicine |
| Brand names | HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY*Technology; HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap |
| First new listing | 2026-07-07 |
| Latest new listing | 2026-07-27 |
| FDA registration number | 3014421917 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.