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Black & Decker(Tm)

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Devices
11

What Black & Decker(Tm) makes

The company manufactures cordless power tools for orthopedic and surgical applications, including drills, drivers, reamers, saws, and cast cutters. These devices are designed for use in orthopedic surgery and patient care, such as bone drilling, cutting, and instrument handling. Battery-powered tools like the 450/800 Drill and 150 Driver/Reamer are part of the portfolio, alongside specialized saws for precise surgical cuts.

The devices fall under FDA Class I and Class II classifications, with regulatory clearance through the 510(k) pathway. They are listed in the FDA’s 510(k) registry. The company is based in the United States.

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

Catalogue11

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  • Power Pack Ref K800314

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

  • 450/800 Drill Ref K812436

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

  • Power Pack Ref K812440

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

  • Sagittal Saw Ref K812438

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

  • 150 Driver/Reamer Ref K800312

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

  • 150 Driver Reamer Ref K812437

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

  • Sagittal Saw Ref K800313

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

  • 450 Drill/800 Drill Ref K800311

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

  • Dual Mpc Charger Ref K800315

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

  • Dual Mpc Charger Ref K812439

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

  • Cast Cutter/Cast Saw/Instrument Ref K820351

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

Rows 1-11 of 11

Frequently asked questions

How many devices does Black & Decker(Tm) have in the registry?

The registry currently lists 11 devices for Black & Decker(Tm). Devices recorded under merged duplicate company entries are counted once.

Which registries list Black & Decker(Tm)'s devices?

Among its 11 most recently registered devices, Black & Decker(Tm) has devices listed in FDA 510(k) (11 devices).

What risk classes do Black & Decker(Tm)'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Black & Decker(Tm)'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Black & Decker(Tm) in the registry?

The most recently registered devices listed for Black & Decker(Tm) include POWER PACK, 450/800 DRILL, SAGITTAL SAW and 150 DRIVER/REAMER.

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