FDA applicant

Canon USA, Inc.

Lake Success, NY48 decisions1984–20090 recalls

FDA records 48 decisions for Canon USA, Inc. (Lake Success, NY) from 1984 to 2009: 48 510(k) clearances. Most are in product codes HKI (Camera, Ophthalmic, Ac-Powered) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Its devices cite 12 predicates, 9 of them its own earlier devices. 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, ophthalmic panel, where it files most

How often FDA has decided Canon USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Canon USA, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Canon USA, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Canon”

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

Canon Medical Systems Corporation 97 Canon, Inc. 43 Canon Inc. -Medical Equipment Group 11 Canon Medical Informatics, Inc. 5 Canon, Inc. - Medical Equpment Group 1 Canon Components, Inc. 1 Canon Medical Systems, USA 1 Canon, Inc.-Utsunomiya Optical Products Operation 1

Canon USA, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Canon”