Eagle Vision, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 59
- FDA recalls
- 4
What Eagle Vision, Inc. makes
Eagle Vision, Inc. manufactures ocular devices for lacrimal (tear duct) drainage and obstruction management, including collagen implants, punctal plugs, and stents designed for temporary or permanent use. Their portfolio includes gel-based inserts, radiopaque punctum plugs, and monocanalicular stents intended to restore tear flow in conditions like nasolacrimal duct obstruction. Additional products include punctal valves and flexible plugs for intra-canalicular placement, as well as temporary collagen implants for short-term drainage support.
The company’s devices are classified under Class II (U) in the U.S. regulatory framework and are listed via the FDA’s 510(k) pathway, demonstrating compliance with pre-market notification requirements. These products are intended for use in the United States, where regulatory oversight ensures their safety and performance for lacrimal drainage applications.
Catalogue
Search and filter all 59 devices- GUDID
- GUDID
Eaglevision Gellanserts, Model Ref 0040 Ref K053333
510(k) 510(k)Monocanalicular Stents, Lacrimal Intubation Sets Ref K030353
510(k) 510(k)Eagle Vision Freeman Radiopague Punctum Plug Ref K905427
510(k) 510(k)Eagle Vision-Freeman(Tm) Punctal Valve Ref K890920
510(k) 510(k)Flexplug Ref K991130
510(k) 510(k)Temporary Intracanalicular Collagen Implant Ref K890919
510(k) 510(k)Ev Monocanalicular Stent (Tm) Ref K883233
510(k) 510(k)
Showing 51-59 of 59
Company details
- DUNS number
- 174318360
- [email protected]
- Phone
- 1-800-222-7584
FDA recalls
FDA recall records list 4 recalls initiated by EAGLE VISION, INC., initiated on 2006-04-12. By recorded status: 4 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 12 Apr 2006 Z-0844-06 Unclassified (pre-2012) Terminated Product may have deformed valves which would cause the valve not to operate properly.
- 12 Apr 2006 Z-0845-06 Unclassified (pre-2012) Terminated Product may have deformed valves which would cause the valve not to operate properly.
- 12 Apr 2006 Z-0846-06 Unclassified (pre-2012) Terminated Product may have deformed valves which would cause the valve not to operate properly.
- 12 Apr 2006 Z-0847-06 Unclassified (pre-2012) Terminated Product may have deformed valves which would cause the valve not to operate properly.