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Cygnus of South Florida, Inc.

United StatesFDA applicant, unverified

Devices
2

What Cygnus of South Florida, Inc. makes

Cygnus of South Florida, Inc. manufactures CRITICALC, a critical care monitoring device designed for real-time patient parameter tracking, and SIMULATOR, a medical training device used for procedural and clinical skill practice in healthcare education.

The company’s portfolio includes Class I and Class II devices, with products authorised via the FDA’s 510(k) pathway. These devices are registered under U.S. regulatory requirements, and the company operates from South Florida.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Criticalc Ref K860854

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Simulator Ref K854265

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

Frequently asked questions

How many devices does Cygnus of South Florida, Inc. have in the registry?

The registry currently lists 2 devices for Cygnus of South Florida, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cygnus of South Florida, Inc.'s devices?

Among its 2 most recently registered devices, Cygnus of South Florida, Inc. has devices listed in FDA 510(k) (2 devices).

What risk classes do Cygnus of South Florida, Inc.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Cygnus of South Florida, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Cygnus of South Florida, Inc. in the registry?

The most recently registered devices listed for Cygnus of South Florida, Inc. include CRITICALC and SIMULATOR.

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