Keeler Instruments, Inc.
United StatesFDA applicant, unverified
- Devices
- 65
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
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 1-50 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.
Frequently asked questions
How many devices does Keeler Instruments, Inc. have in the registry?
The registry currently lists 65 devices for Keeler Instruments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Keeler Instruments, Inc.'s devices?
Among its 50 most recently registered devices, Keeler Instruments, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Keeler Instruments, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Keeler Instruments, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Keeler Instruments, Inc.?
FDA recall records list 1 recall initiated by Keeler Instruments, Inc., the most recent initiated on 8 Jan 2008. 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 Keeler Instruments, Inc. in the registry?
The most recently registered devices listed for Keeler Instruments, Inc. include HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER, KEELER TEARSCOPE-PLUS, PANORAMIC LOUPES - VARIOUS and VICKERS ERGOMATIC MICROS INSTR-LONG R OR L HANDED.