Data / Medical devices / Ear Wick
Ear Wick (KCN): 14 FDA-registered makers in 6 countries
14 establishments in 6 countries are registered with the FDA to make Ear Wick (product code KCN, Class 1, 21 CFR 874.5220). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on October 18, 2006, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KCN
- Device class
- 1
- Regulation
- 874.5220
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| India | 3 |
| Pakistan | 1 |
| China | 1 |
| Mexico | 1 |
| Dominican Republic | 1 |
Makers of Ear Wick
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 |
|---|---|---|---|---|---|---|---|---|
| Beaver-Visitec International, Inc. | Waltham, MA, United States | Specification developer | 1 | February 1, 1993 | 0 | 0 | 0 | api.fda.gov |
| Aegis Lifesciences Private Limited | Ahmedabad Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carwild Corp. | New London, CT, United States | Contract manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Endure Industries, Inc. | Homer, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eon Meditech Pvt. Ltd. | Surat Gujarat, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Falcon Surgical Co. (Pvt.) Ltd. | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gesco Healthcare Private Limited | CHENNAI, Tamil Nadu, India | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huizhou Foryou Medical Devices Co.,ltd. | HuiZhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hydrofera, LLC. | Manchester, CT, United States | Contract 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 | |
| Medsorb Dominicana, S.A. | San Pedro De Macoris, Dominican Republic | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Xomed, Inc. | Mystic, CT, United States | Manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Summit Medical LLC | Saint Paul, MN, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 18, 2006. 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.