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Toray Industries (America), Inc.

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Devices
20

What Toray Industries (America), Inc. makes

Toray Industries (America), Inc. manufactures hemodialysis devices, including TORAYSULFONE and FILTRYZER dialyzers, as well as specialized angiographic catheters like the TORAY ANTHRON series. Their portfolio also covers superselective guidewires, aorta bypass tubes, and related vascular access products for interventional radiology and cardiovascular procedures.

The company’s devices are regulated under FDA Class II and Class III classifications, with submissions recorded in the 510(k) and PMA pathways. Products are listed in the US, where the manufacturer is based.

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

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  • Toraysulfone Dialyzer Ref K002512

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

  • Filtryzer Ref K942681

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

  • Filtryzer(Tm) Ref K935471

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

  • Toray Anthron Angiographic Catheters Ref K872983

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

  • Toray Superselective Guidewires, Additional Types Ref K874542

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

  • Toray Superselective Guidewire, Superselec Y-K Type Ref K861115

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

  • Anthron Catheters & Sets Ref K861117

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

  • Toray Anthron Aorta Bypass Tubes Ref K872762

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

  • Toraysulfone Dialyzer, Bs-L Series Ref K030050

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

  • Toray Filtryzer Dialyzers Ref K884339

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

  • Torayguide Guidewire Ref K042370

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

  • Filtryzer Ref K940910

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

  • Toray Vascular Prosthesis Ref K884083

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

  • Toray Filtryzer Bk Series Ref K883407

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

  • Toray Anthron Bypass Tubes Ref K861116

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

  • Hemofeel-Ch, Models Ch-0.35l, Ch-0.6l, Ch-1.0l Ref K994198

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

  • Modified Toray Filtryzer Dialyzers Ref K882158

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

  • Toray Anthron P-U Catheters Ref K881236

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

  • Inoue Balloon Catheter Ref P910054

    Active Regimes: PMA Registry: PMA Class:III

  • Toray Soft Contact Lenses Ref P840044

    Withdrawn Regimes: PMA, withdrawn Registry: PMA Class:III

Rows 1-20 of 20

Frequently asked questions

How many devices does Toray Industries (America), Inc. have in the registry?

The registry currently lists 20 devices for Toray Industries (America), Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Toray Industries (America), Inc.'s devices?

Among its 20 most recently registered devices, Toray Industries (America), Inc. has devices listed in FDA 510(k) (18 devices) and FDA PMA (2 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Toray Industries (America), Inc.'s devices fall under?

Among its 20 most recently registered devices, the classes recorded for Toray Industries (America), Inc.'s devices are Class II and Class III. Each device page shows its own class and authorisation.

What are the newest devices from Toray Industries (America), Inc. in the registry?

The most recently registered devices listed for Toray Industries (America), Inc. include TORAYSULFONE DIALYZER, FILTRYZER, FILTRYZER(TM) and TORAY ANTHRON ANGIOGRAPHIC CATHETERS.

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