Keeler Instruments, Inc.
United StatesFDA applicant, unverified
- Devices
- 65
- FDA recalls
- 1
What Keeler Instruments, Inc. makes
Keeler Instruments, Inc. manufactures diagnostic and surgical ophthalmic devices, including central visual field screeners, tear analysis instruments, ergonomic microsurgical instruments, transilluminators, ophthalmic YAG lasers, widefield specular microscopes, indirect ophthalmoscopes, cryotherapy tools, and laser systems for retinal procedures.
The company’s portfolio includes Class I and Class II devices, with products listed via the FDA’s 510(k) pathway. Keeler Instruments, Inc. is headquartered in the United States.
Catalogue
Search and filter all 65 devicesShowing 51-65 of 65
FDA recalls
FDA recall records list 1 recall initiated by Keeler Instruments, Inc., initiated on 2008-01-08. By recorded status: 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 8 Jan 2008 Z-1132-2008 Unclassified (pre-2012) Terminated Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.