Data / Medical devices / Honduras / O&M Halyard Honduras S.A de C.V.
O&M Halyard Honduras S.A de C.V.: FDA-registered device maker in VILLANEVA Cortes, Honduras, 12 510(k) clearances
O&M Halyard Honduras S.A de C.V. is registered with the FDA (registration 9680646) in VILLANEVA Cortes, Honduras. It lists 5 device types. The FDA files 12 510(k) clearances under its listings, the newest dated July 21, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9680646
- FEI number
- 1000582923
- Address
- Carretera Tegucigalpa, VILLANEVA Cortes, Honduras, --
- Owner or operator
- O&M Halyard, Inc. (10057479)
- Roles
- Manufacturer
- First device listed
- April 27, 2018
- Registered through
- 2026
- Brand names listed
- AERO BLUE SURGICAL GOWN, Aero Blue Performance Surgical Gowns, Aero Chrome Breathable Performance Surgical Gown, Aero Chrome Select, GOWN, DRAPE PACKS, HALYARD BASICS SURGICAL GOWN, HALYARD GOWN, HALYARD PROCEDURE GOWN and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Manufacturer | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 21, 2021 | K210688 | AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown | FYA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| March 16, 2020 | K200522 | AERO CHROME* Breathable Performance Surgical Gowns | FYA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| December 13, 2019 | K192362 | Aero Blue Performance Surgical Gowns | FYA | Substantially Equivalent | O&M Halyard, Inc. | accessdata.fda.gov |
| April 21, 2017 | K162930 | Aero Chrome* Select Breathable Performance Surgical Gowns | FYA | Substantially Equivalent | Halyard Health, Inc. | accessdata.fda.gov |
| April 13, 2016 | K153255 | Aero Chrome* Breathable Performance Surgical Gown | FYA | Substantially Equivalent | Halyard Health, Inc. | accessdata.fda.gov |
| June 9, 2014 | K140539 | AERO BLUE PERFORMANCE SURGICAL GOWN | FYA | Substantially Equivalent | Kimberly-Clark Corporation | accessdata.fda.gov |
| March 19, 2010 | K093115 | KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 | FYA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| September 3, 2008 | K080795 | ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN | FYA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| July 10, 1998 | K981393 | MICROCOOL SURGICAL GOWN | FYA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| June 23, 1988 | K880382 | KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWN | FYA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| June 11, 1984 | K842115 | SPUNGARD & SURG. DRAPES-GOWNS & PACKS | KKX | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
| December 20, 1978 | K781682 | SURGICAL GOWNS & DRAPES | FYA | Substantially Equivalent | Kimberly-Clark Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Gown, Surgical
- All makers of Drape, Surgical, Antimicrobial
- All makers of Non-Surgical Gown
- All makers of Accessory, Surgical Apparel
- All makers of Gown, Isolation, Surgical
Updated July 21, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.