Keeler, Ltd. is one of 18904 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Keeler, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: D-KAT Z-YPE, CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES, KEELER SLIT LAMP H-SERIES
4
Total
4
Cleared
0
Denied
Keeler, Ltd. is a UK-based manufacturer of ophthalmic diagnostic and surgical instruments. The company operates with a manufacturing facility in Broomall, US, and is part of the Halma group. Keeler specializes in slit lamps, tonometers, cryosurgical systems, and related diagnostic equipment for eye care professionals.
The company has received 4 FDA 510(k) clearances from 4 total submissions. All submissions have focused on ophthalmic devices, with clearances spanning 2010 to 2014. Notable cleared devices include slit lamp systems, applanation tonometers, and cryosurgical consoles with disposable probes. Keeler is currently inactive in the FDA 510(k) database, with no new submissions recorded in the past decade. This profile represents a historical regulatory record.
Explore the complete list of device names, product codes, and clearance dates in the database to review Keeler's specific submissions and cleared ophthalmic instruments.
510(k) submissions have been managed by Underwriters Laboratories, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Keeler, Ltd.
4 devices