FDA applicant

Biosys Biyomedikal Muhendislik San. VE Tic. A.S.

Ankara, TR1 decision2024–20240 recalls

FDA records 1 decision for Biosys Biyomedikal Muhendislik San. VE Tic. A.S. (Ankara, TR) in 2024: 1 510(k) clearance. All are in product code ETN (Stimulator, Nerve). 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, ear, nose and throat panel, where it files most

How often FDA has decided Biosys Biyomedikal Muhendislik San. VE Tic. A.S.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Biosys Biyomedikal Muhendislik San. VE Tic. A.S. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biosys Biyomedikal Muhendislik San. VE…’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 “Biosys”

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

Biosys AB (Publ) 2 Biosys Laboratories, Inc. 1 Biosys Co., Ltd. 1

Biosys Biyomedikal Muhendislik San. VE Tic. A.S.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Biosys”