Data / Medical devices / Screw, Oral
Screw, Oral (KBW): 8 FDA-registered makers in 6 countries
8 establishments in 6 countries are registered with the FDA to make Screw, Oral (product code KBW, Class 1, 21 CFR 874.4420). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on March 24, 1994, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KBW
- Device class
- 1
- Regulation
- 874.4420
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| Taiwan | 2 |
| China | 2 |
| United Kingdom | 1 |
| Pakistan | 1 |
| Mexico | 1 |
| Germany | 1 |
Makers of Screw, Oral
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 |
|---|---|---|---|---|---|---|---|---|
| Enter Medical Corporation | Chiayi County Chiayi(County), Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Medical (dongguan) Ltd. | DONGGUAN CITY Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flexicare Medical Ltd. | RHONDDA CYNON TAFF Wales, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jin Hsiang Ent Co. Ltd | Changhua, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MDF Instruments Medifriend Inc. | Song Jiang District, Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Med Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 24, 1994. 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.