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Obsidio, Inc.

Country not established

Devices
1

What Obsidio, Inc. makes

Obsidio, Inc. manufactures the GEM device, which is a Class II medical device.

The company is based in the US and the GEM device is listed in the FDA 510(k) registry.

AI-generated from registry data, 26 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Gem Ref K213385 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

Frequently asked questions

How many devices does Obsidio, Inc. have in the registry?

The registry currently lists 1 device for Obsidio, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Obsidio, Inc.'s devices?

Among its 1 most recently registered device, Obsidio, Inc. has devices listed in FDA 510(k) (1 device).

What risk classes do Obsidio, Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for Obsidio, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Obsidio, Inc. in the registry?

The most recently registered devices listed for Obsidio, Inc. include GEM.

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