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Shiley, Inc.

United StatesFDA applicant, unverified

Devices
175

What Shiley, Inc. makes

Shiley, Inc. manufactures cardiovascular surgical devices, including venous occlusion clamps, heater-cooler units, Y-connectors with rotators, cardiotomy reservoirs, venous reservoirs, embolism removal catheters, arterial cannulas, mechanical heart valves, cardioplegia adaptors, extracorporeal circulation pumps, blood filters, and remote control modules for intracardiac procedures.

The company’s products are regulated under FDA classifications, with devices spanning Class I, Class II, and Class III. Authorisation records include 510(k) clearances and Premarket Approval Applications (PMA). The manufacturer is based in the United States.

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

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Frequently asked questions

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

The registry currently lists 175 devices for Shiley, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Shiley, Inc.'s devices?

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

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

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

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

The most recently registered devices listed for Shiley, Inc. include STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP, BASIC HEATER-COOLER UNIT, 115/100V 16-02-20, SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR and EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR.

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