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Extracorporeal Medical Specialities, Inc.

United StatesFDA applicant, unverified

Devices
69

What Extracorporeal Medical Specialities, Inc. makes

Extracorporeal Medical Specialties, Inc. manufactures medical devices for renal dialysis and respiratory support, including disposable dialyzers (e.g., parallel plate and alternate membrane types), ultrafiltration controllers and monitors, tracheostomy tubes for short- and long-term use, and accessories like luer connectors, venous reservoir bags, and membrane oxygenators.

The company’s portfolio includes Class II and Class III devices, with products authorised via FDA 510(k) clearance. These devices are listed in the FDA’s 510(k) registry, reflecting their regulatory status in the United States.

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

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Frequently asked questions

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

The registry currently lists 69 devices for Extracorporeal Medical Specialities, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Extracorporeal Medical Specialities, Inc.'s devices?

Among its 50 most recently registered devices, Extracorporeal Medical Specialities, Inc. has devices listed in FDA 510(k) (50 devices).

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

Among its 50 most recently registered devices, the classes recorded for Extracorporeal Medical Specialities, Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Extracorporeal Medical Specialities, Inc. include MALE LUER CONNECTOR & HINGED CAP, PARALLEL PLATE DIALYZER HOLDER, TRACHEOSTOMY TUBES, SHORT AND LONG TERM and ULTRAFILTRATION CONTROLLER.

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