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Radkor, Inc.

United StatesFDA applicant, unverified

Devices
10

What Radkor, Inc. makes

Radkor, Inc. manufactures surgical instruments and medical devices, including forceps (e.g., RADKOR SFR-70 and SFC-21), retractors (e.g., RADKOR BS-10 and BS-10T), and specialized surgical tools like the RADKOR XG-515 and XG-325. The portfolio also includes RF ablation devices (e.g., RADKOR RF-159) and surgical clamps (e.g., RADKOR CST-18). Additional products include diagnostic tools like the RADKOR DXG-650R and surgical trays (e.g., RADKOR KOB-84). The company produces both general-purpose and procedure-specific instruments for surgical and procedural applications.

Radkor’s devices are classified under FDA’s Class I and Class II categories, with most requiring 510(k) clearance. The company’s products are listed in the FDA’s 510(k) database, reflecting their regulatory status in the United States. The manufacturer operates from its base in the US, adhering to applicable medical device regulations.

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

Catalogue10

Newest first, rows 1-10 of 10

  • Radkor Sfr-70 Ref K883864

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

  • Radkor, Rf-159 Ref K883885

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

  • Radkor, Cst-18 Ref K882563

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

  • Radkor, Xg-515 Ref K883081

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

  • Radkor Xg-325 Ref K881696

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

  • Radkor Sfc-21 Ref K881701

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

  • Radkor Kob-84 Ref K881700

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

  • Radkor Dxg-650R Ref K895969

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

  • Radkor TS10-B Ref K892196

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

  • Radkor Bs-10 And Bs-10T Ref K891395

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

Frequently asked questions

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

The registry currently lists 10 devices for Radkor, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Radkor, Inc.'s devices?

Among its 10 most recently registered devices, Radkor, Inc. has devices listed in FDA 510(k) (10 devices).

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

Among its 10 most recently registered devices, the classes recorded for Radkor, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Radkor, Inc. include RADKOR SFR-70, RADKOR, RF-159, RADKOR, CST-18 and RADKOR, XG-515.

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