Data / Medical devices / Burr, Corneal, Battery Powered, Rust Ring Removal
Burr, Corneal, Battery Powered, Rust Ring Removal (OHW): 9 FDA-registered makers in 3 countries
9 establishments in 3 countries are registered with the FDA to make Burr, Corneal, Battery Powered, Rust Ring Removal (product code OHW, Class 1, 21 CFR 886.4070). 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 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OHW
- Device class
- 1
- Regulation
- 886.4070
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 3 |
| Germany | 2 |
Makers of Burr, Corneal, Battery Powered, Rust Ring Removal
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 |
|---|---|---|---|---|---|---|---|---|
| Gebr. Brasseler GMBH & Co. KG | LEMGO North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huizhou Foryou Medical Devices Co.,ltd. | HuiZhou Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katena Products, Inc. | Parsippany, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katena Products, Inc. | Randolph, NJ, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phoenix Instruments, Inc. | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RZ Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Create Technology Co.,ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Alger Company, Inc. | Lago Vista, TX, United States | 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.