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Gateway Alloys, Inc.

United StatesFDA applicant, unverified

Devices
31

What Gateway Alloys, Inc. makes

Gateway Alloys, Inc. manufactures solder alloys and precious metal alloys used in medical device fabrication, including GPW-SF, SOLDER GPW, and AURORA 53. Their portfolio also includes palladium-based alloys like PALLADIA 85 (PM-13) and PALLADIA 75 (PM-11), as well as copper-nickel alloys such as PACIFIC 52 (CB-39) and OZARK 40. Additional products include OSAGE 76, CONCORD 82, and LA PLATA 39, designed for specialized soldering and bonding applications in medical equipment.

These products are classified as Class II medical devices and are listed under the FDA’s 510(k) pathway. The company’s alloys are intended for use in manufacturing medical components, adhering to regulatory standards for materials in direct or indirect patient contact. Gateway Alloys, Inc. is based in the United States.

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

Catalogue31

Newest first, rows 1-31 of 31

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  • Gpw-Sf Ref K011659

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

  • Solder Gpw Ref K964713

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

  • Aurora 53 Ref K964949

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

  • Solder 585 Ref K964707

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

  • Pacific 52 (Cb-39) Ref K964464

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

  • Palladia 85 (Pm-13) Ref K964838

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

  • Ozark 40 Ref K964477

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

  • Ozark 20 Ref K964566

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

  • Osage 76 Ref K964478

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

  • Palladia 75 (Pm-11) Ref K964466

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

  • Concord 82 Ref K011628

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

  • La Plata 39 Ref K964789

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

  • Aurora 52 (Pm-01) Ref K964948

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

  • El Dorado 55 Ref K964788

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

  • Solder Gpy Ref K964705

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

  • El Dorado 75 Ref K964567

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

  • El Dorado 40 Ref K964941

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

  • Solder 650 Ref K964706

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

  • El Dorado 58 Ref K964569

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

  • Taos 28 Ref K964940

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

  • Ozark 46 Ref K964568

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

  • Concord 72 Ref K011626

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

  • Palladia 76 Ref K964572

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

  • Piedmont 70 (Ch-35) Ref K964573

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

  • La Plata 40 Ref K964792

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

  • La Plata 28 (Pm-28) Ref K964950

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

  • Concord 88 Ref K011661

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

  • Pacific 56 (Cb-40) Ref K964837

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

  • Solder 615 Ref K964708

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

  • De Oro 77 Ref K964476

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

  • La Plata 34 (Pm-25) Ref K964465

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

Rows 1-31 of 31

Frequently asked questions

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

The registry currently lists 31 devices for Gateway Alloys, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gateway Alloys, Inc.'s devices?

Among its 31 most recently registered devices, Gateway Alloys, Inc. has devices listed in FDA 510(k) (31 devices).

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

Among its 31 most recently registered devices, the classes recorded for Gateway Alloys, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Gateway Alloys, Inc. include GPW-SF, SOLDER GPW, AURORA 53 and SOLDER 585.

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