510(k) Report

FDA applicant

Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi

Yenimahalle-Ankara, TR1 decision2024–20240 recalls

FDA records 1 decision for Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi (Yenimahalle-Ankara, TR) in 2024: 1 510(k) clearance. All are in product code FLL (Continuous Measurement Thermometer). 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, general hospital panel, where it files most

How often FDA has decided Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Metko Medikal VE Tibbi Cihazlar Dis…’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 “Metko”

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