Data / Medical devices / Hood, Oxygen, Infant
Hood, Oxygen, Infant (FOG): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Hood, Oxygen, Infant (product code FOG, Class 1, 21 CFR 868.5700). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on November 18, 1997, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FOG
- Device class
- 1
- Regulation
- 868.5700
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 4 |
| Turkey | 1 |
| India | 1 |
Makers of Hood, Oxygen, Infant
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 |
|---|---|---|---|---|---|---|---|---|
| Amron International, Inc. | Vista, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ecollink Non-Woven Company Limited | Hongkong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Feiteng Protective Products Co.,ltd | Xiantao Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plasti-Med Plastik Medikal Urunler San. Ve Tic. Ltd. Sti. | Tuzla Istanbul, Turkey | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polymed (xiamen) Plastic Industrial Co.,ltd. | XIAMEN Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sea-Long Medical Systems, LLC | Waxahachie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Salaera, LLC d.b.a Maxtec | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tekna Manufacturing Pvt. Ltd. | Chennai Tamil Nadu, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan Lucky Star Non Woven Products Co Ltd | Wuhan Hubei, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 18, 1997. 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.