Eagle Vision, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 59
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
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 devicesShowing 1-50 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.
Frequently asked questions
How many devices does EAGLE VISION, INC. have in the registry?
The registry currently lists 59 devices for EAGLE VISION, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list EAGLE VISION, INC.'s devices?
Among its 50 most recently registered devices, EAGLE VISION, INC. has devices listed in FDA GUDID (50 devices).
Are there FDA recall records for EAGLE VISION, INC.?
FDA recall records list 4 recalls initiated by EAGLE VISION, INC., the most recent initiated on 2006-04-12. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from EAGLE VISION, INC. in the registry?
The most recently registered devices listed for EAGLE VISION, INC. include DURAPLUG 0078, SUPERFLEX 31702, SUPERFLEX 31752 and EAGLEFLEX 30772.