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Smith'S Ostomy Products, Inc.

United StatesFDA applicant, unverified

Devices
2

What Smith'S Ostomy Products, Inc. makes

Smith’s Ostomy Products, Inc. manufactures ostomy care accessories, including deep convex face plates for securing ostomy appliances to curved abdominal contours and ostomate third-hand tools designed to assist with ostomy pouch changes and appliance adjustments.

The company’s products are classified as Class I medical devices under FDA regulations and are listed via 510(k) clearance. The manufacturer operates from the United States.

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

Catalogue2

Newest first, rows 1-2 of 2

  • Deep Convex Face Plate Ref K820493

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Ostomate Third Hand Ref K802424

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

Frequently asked questions

How many devices does Smith'S Ostomy Products, Inc. have in the registry?

The registry currently lists 2 devices for Smith'S Ostomy Products, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Smith'S Ostomy Products, Inc.'s devices?

Among its 2 most recently registered devices, Smith'S Ostomy Products, Inc. has devices listed in FDA 510(k) (2 devices).

What risk classes do Smith'S Ostomy Products, Inc.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Smith'S Ostomy Products, Inc.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Smith'S Ostomy Products, Inc. in the registry?

The most recently registered devices listed for Smith'S Ostomy Products, Inc. include DEEP CONVEX FACE PLATE and OSTOMATE THIRD HAND.

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