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American Biomedical Products, Inc.

Country not established

Devices
1

What American Biomedical Products, Inc. makes

American Biomedical Products, Inc. manufactures the FRAGTEX, a Class I medical device designed for surgical or procedural use in tissue fragmentation or preparation.

The FRAGTEX is regulated under the FDA’s 510(k) pathway as a Class I device and is listed in the U.S. regulatory database. The company is based in the United States.

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

Catalogue1

Newest first, rows 1-1 of 1

  • B. Fragtex Ref K881380

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

Frequently asked questions

How many devices does American Biomedical Products, Inc. have in the registry?

The registry currently lists 1 device for American Biomedical Products, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list American Biomedical Products, Inc.'s devices?

Among its 1 most recently registered device, American Biomedical Products, Inc. has devices listed in FDA 510(k) (1 device).

What risk classes do American Biomedical Products, Inc.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for American Biomedical Products, Inc.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from American Biomedical Products, Inc. in the registry?

The most recently registered devices listed for American Biomedical Products, Inc. include B. FRAGTEX.

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