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Diamed Division Ill. Tool Works, Inc.

United StatesFDA applicant, unverified

Devices
7

What Diamed Division Ill. Tool Works, Inc. makes

Diamed Division produces sterile urinary catheters and drainage accessories, including touchless clean-cath systems, foley catheter kits, home-use catheters, external urinary appliances, and sterile urethral catheter kits. Their product line also includes drainage units and specific models (600, 900, 960, 964) designed for urinary management.

The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. These products are listed in the FDA’s 510(k) database, adhering to U.S. medical device compliance standards. The manufacturer operates from the United States.

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

Catalogue7

Newest first, rows 1-7 of 7

  • Touchless Clean-Cath Ref K802665 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Touchless Tm Foley Catheter Kit Ref K790728

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Touchless Home-Cath Ref K812281

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Female External Urinary Appliance Ref K823450

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Urinary Drainage Unt Ref K802664

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Sterile Urethral Catheter Kit Ref K760897

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Diamed Models 600, 900, 960, 964 Ref K854953

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

Frequently asked questions

How many devices does Diamed Division Ill. Tool Works, Inc. have in the registry?

The registry currently lists 7 devices for Diamed Division Ill. Tool Works, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Diamed Division Ill. Tool Works, Inc.'s devices?

Among its 7 most recently registered devices, Diamed Division Ill. Tool Works, Inc. has devices listed in FDA 510(k) (7 devices).

What risk classes do Diamed Division Ill. Tool Works, Inc.'s devices fall under?

Among its 7 most recently registered devices, the classes recorded for Diamed Division Ill. Tool Works, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Diamed Division Ill. Tool Works, Inc. in the registry?

The most recently registered devices listed for Diamed Division Ill. Tool Works, Inc. include TOUCHLESS CLEAN-CATH, TOUCHLESS TM FOLEY CATHETER KIT, TOUCHLESS HOME-CATH and FEMALE EXTERNAL URINARY APPLIANCE.

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