FDA applicant

Aktina Medical Corporation

Congers, NY4 decisions2013–20190 recalls

FDA records 4 decisions for Aktina Medical Corporation (Congers, NY) from 2013 to 2019: 4 510(k) clearances. All are in product code IYE (Accelerator, Linear, Medical). Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Aktina Medical Corp.”.

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 Aktina Medical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Aktina Medical Corporation by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Aktina”

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

Aktina Medical Physics Corp. 13

Aktina Medical Corporation

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Aktina”