Manufacturer registered with FDA
O&M Halyard, Inc.
Alpharetta, GA, United States. Lists 3 dental device types with FDA across 6 registered establishments.
- Device types listed
- 3
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 14687 registrations outside the US
- Establishments
- 6Honduras, Mexico, United States
Registered in 14 markets
Where regulators' registries name O&M Halyard, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | O&M Halyard, Inc. | 3 device types | — | Below |
| Colombia | INVIMA | Registration holder | O&M HALYARD, INC.LA ADA DE ACUNA · O&M HALYARD, INC | 305 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | O&M HALYARD, INC. | 121 | 2019–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | O & M HALYARD, INC. | 64 | 2000–2022 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | O & M Halyard, Inc. | 51 | 2025–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | O&M HALYARD, INC.Medical Action Industries, Inc. 306 · O&M Halyard, Inc. | 35 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | O&M Halyard, Inc. | 33 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | O&M Halyard Inc. | 33 | — | Pure Global AI |
| Australia | TGA | Manufacturer | O&M Halyard Inc | 21 | 2019–2022 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | O&M Halyard Inc. | 13 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | O&M Halyard, Inc | 4 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | O&M HALYARD, INC. | 3 | 2020–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | O&M Halyard, Inc.LA ADA DE ACUNA | 3 | 2016–2018 | Pure Global AI |
| China | NMPA | Registration holder | 欧文哈利涯德公司O&M Halyard, Inc. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What O&M Halyard, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Patient Personal Hygiene KitNSB · Class 1 | — | Maker | Hygiene KitICU Hygiene KitPatient Admission KitPatient Personal Hygiene KitPatient Welcome Pack | 2015 |
| General Purpose Dental TrayOFX · Class 1 | — | Maker | General Purpose Dental TrayNICU Oral Care KitOral Care Kit | 2015 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | — | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305FDA reg. 1047429 | TOANO, VA, United States | Manufacturer, Repacker / relabeler |
| Honduras Kitting, S.A.FDA reg. 3035642068 | Villanueva Cortes, Honduras | Contract manufacturer |
| La Ada de AcunaFDA reg. 9616096 | CIUDAD DE ACUNA Coahuila, Mexico | Manufacturer |
| MEDICAL ACTION INDUSTRIES, INC. 306FDA reg. 1030451 | ARDEN, NC, United States | Contract manufacturer, Manufacturer, Repacker / relabeler |
| O&M Halyard, Inc.FDA reg. 3014421917 | Alpharetta, GA, United States | Repacker / relabeler |
| Southaven Distribution CenterFDA reg. 3012143814 | Southaven, MS, United States | Repacker / relabeler |
Other names on FDA records
LA Ada de Acuna · Medical Action Industries, Inc. 306 · Honduras Kitting, S.A. · Southaven Distribution Center · Avid Medical, Inc. A Medical Action Ind. Company 305
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10057479, 10039033). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.