FDA applicant

Black & Decker (Tm)

Mchenry, IL11 decisions1980–19820 recalls

FDA records 11 decisions for Black & Decker (Tm) (Mchenry, IL) from 1980 to 1982: 11 510(k) clearances. Most are in product codes KIJ (Instrument, Surgical, Orthopedic, Dc-Powered…) and GEY (Motor, Surgical Instrument, Ac-Powered). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Black & Decker (Tm)’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Black & Decker (Tm) since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Black & Decker (Tm) by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Black”

FDA records each applicant name separately; these may or may not be the same firm.

Black & Black Surgical, Inc. 4 Black Box Medical 3 Black Diamond Video, Inc. 2

Black & Decker (Tm)

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Black”