Data / Medical devices / Oral Airway Assist
Oral Airway Assist (PHS): 13 FDA-registered makers in 7 countries
13 establishments in 7 countries are registered with the FDA to make Oral Airway Assist (product code PHS, Class 1, 21 CFR 868.5110). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PHS
- Device class
- 1
- Regulation
- 868.5110
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 2 |
| Belgium | 1 |
| Malaysia | 1 |
| Ukraine | 1 |
| India | 1 |
| Taiwan | 1 |
Makers of Oral Airway Assist
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| ADDEV Materials Healthcare | Menomonee Falls, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coastal Plastics | Alvin, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forwardontics | San Mateo, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GF Health Products, Inc | Atlanta, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jada Medical LLC | Potomac, MD, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Materialise N.V. | LEUVEN Vlaams Brabant, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Materialise Sdn Bhd | Petaling Jaya Selangor, Malaysia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Materialise USA, LLC. | Plymouth, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Materialise Ukraine, Rep. office | Kyiv Kyyiv, Misto, Ukraine | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Narang Medical, Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rusun Medical Co., Ltd | Yichun City Jiangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sentronic International Corp. | Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.