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Omni-Guide Holdings, Inc.

United Statesfrom the FDA registration address FDA establishment FEI 3005350457

Devices
2
Registrations
FDA
FDA recalls
0

What Omni-Guide Holdings, Inc. makes

Omni-Guide Holdings, Inc. manufactures surgical laser fibers, including the OmniGuide RFID Surgical Laser Fibers and LISA Laser Surgical Fibers.

These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

Company details

FDA FEI number
3005350457
Address
43 Manning Road, Billerica, MA, 01821

Frequently asked questions

How many devices does Omni-Guide Holdings, Inc. have in the registry?

The registry currently lists 2 devices for Omni-Guide Holdings, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Omni-Guide Holdings, Inc.'s devices?

Among its 2 most recently registered devices, Omni-Guide Holdings, Inc. has devices listed in FDA 510(k) (2 devices).

What risk classes do Omni-Guide Holdings, Inc.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Omni-Guide Holdings, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Omni-Guide Holdings, Inc. in the registry?

The most recently registered devices listed for Omni-Guide Holdings, Inc. include OmniGuide RFID Surgical Laser Fibers and LISA Laser Surgical Fibers.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company and no recalls are recorded.