O&M Halyard, Inc. (manufacturer, Alpharetta, GA): 11 new FDA device listings, incl. wrap, sterilization
O&M Halyard, Inc. (Alpharetta, Georgia): 11 new FDA device listings, incl. wrap, sterilization. Its amount of 11 is top-decile (94th percentile of 2,570 records). Dated 100 days ago, it serves as a historical benchmark. Score 85/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 11 · 94th percentile of 2,570 DeviceEstablishmentPulse records · 11.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 42 related GA DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 94th of 2,570 (median 1, 11.0x median) |
| Peer records CSV (43 GA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-07-27
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (GA first): Drive Northpoint, LLC (manufacturer, Palmetto, GA) · Hsg-S Corp (manufacturer, Savannah, GA) · C.R. Bard, Inc. (contract sterilizer, Covington, GA) · Emsere, Inc. (repackager or relabeler, Peachtree City, GA) · C.R. Bard, Inc. (contract sterilizer, Madison, GA) · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: O&M Halyard, Inc. and 43 Georgia peers
- Georgia DeviceEstablishmentPulse records like this one: 43
- O&M Halyard, Inc.'s amount: 94th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Georgia peer: $8,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
85 / 100 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.
What is the DeviceEstablishmentPulse record for O&M Halyard, Inc. in Alpharetta, Georgia?
O&M Halyard, Inc. (Alpharetta, GA), a manufacturer, added 11 FDA device listings between 2026-07-07 and 2026-07-27.
How does O&M Halyard, Inc. compare to other Georgia DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 11 is 11.0x the median of 1 across 2,570 records. It is 100 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.
O&M Halyard, Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| O&M Halyard, Inc. | Alpharetta, GA | 11 | 94th | 2026-07-27 |
| Boston Scientific Corporation | Coventry, RI | 10 | 93rd | 2026-10-16 |
| Paragon 28 | Englewood, CO | 9 | 92nd | 2026-10-08 |
| Surgentec LLC | Boca Raton, FL | 15 | 96th | 2026-10-16 |
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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.