FDA applicant

Topslane

Pleasnat Hill, CA1 decision1997–19970 recalls

FDA records 1 decision for Topslane (Pleasnat Hill, CA) in 1997: 1 510(k) clearance. All are in product code IYE (Accelerator, Linear, Medical). Its devices cite 1 predicate, 0 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Topslane since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Topslane”

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

Topslane International, LLC 1

Topslane

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Topslane”