FDA applicant

Geotek Medikal Ltd Sti

Ankara, TR2 decisions2017–20230 recalls

FDA records 2 decisions for Geotek Medikal Ltd Sti (Ankara, TR) from 2017 to 2023: 2 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and ITX (Transducer, Ultrasonic, Diagnostic). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Geotek Medikal Ltd Sti’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Geotek Medikal Ltd Sti by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Geotek Medikal Ltd Sti’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

Geotek Medikal Ltd Sti

Which product codes does it file in?

What has FDA decided for it lately?