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Orbusneich Medical, Inc.

United StatesFDA applicant, unverified

Devices
4

What Orbusneich Medical, Inc. makes

Orbusneich Medical, Inc. makes the Sapphire II PRO and Sapphire NC Plus devices.

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

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4

Newest first, rows 1-4 of 4

  • Sapphire Ref K103657

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Sapphire Nc Ref K103808

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Sapphire II PRO Ref K163114

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Sapphire NC Plus Ref K162209

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

Frequently asked questions

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

The registry currently lists 4 devices for Orbusneich Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Orbusneich Medical, Inc.'s devices?

Among its 4 most recently registered devices, Orbusneich Medical, Inc. has devices listed in FDA 510(k) (4 devices).

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

Among its 4 most recently registered devices, the classes recorded for Orbusneich Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Orbusneich Medical, Inc. include SAPPHIRE, SAPPHIRE NC, Sapphire II PRO and Sapphire NC Plus.

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