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Mallinckrodt Critical Care

Country not established

Devices
92

What Mallinckrodt Critical Care makes

The company produces diagnostic reagents and monitoring devices, including glucose test kits (O-toluidine-based), radioimmunoassay (RIA) kits for thyroid hormones (T4) and C-peptide, and electrolyte test kits for sodium and potassium. It also manufactures medical-grade diluents, temperature monitoring tools like the Hi-Lo Temp Model 8700 patient monitor and myocardial temperature sensors, and specialized infusion kits for coronary procedures. Additional products include a foam nasal airway, bronchoscopy catheters, and thermocouple adaptors for temperature measurement.

The portfolio consists of Class I and Class II medical devices, with several products authorised via the FDA’s 510(k) pathway. These devices are listed under US regulatory requirements, and the company operates from 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 Mallinckrodt Critical Care have in the registry?

The registry currently lists 92 devices for Mallinckrodt Critical Care. Devices recorded under merged duplicate company entries are counted once.

Which registries list Mallinckrodt Critical Care's devices?

Among its 50 most recently registered devices, Mallinckrodt Critical Care has devices listed in FDA 510(k) (50 devices).

What risk classes do Mallinckrodt Critical Care's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Mallinckrodt Critical Care's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Mallinckrodt Critical Care in the registry?

The most recently registered devices listed for Mallinckrodt Critical Care include FOAM NOSE, ISOTONIC DILUENT, HI-LO TEMP THERMOCOUPLE TO THERMISTER ADAPTOR and GLUCOSE REAGENT (O-TOLUIDINE).

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