FDA applicant

Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi

Izmir, TR1 decision2023–20230 recalls

FDA records 1 decision for Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi (Izmir, TR) in 2023: 1 510(k) clearance. All are in product code FYA (Gown, Surgical). 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 and plastic surgery panel, where it files most

How often FDA has decided Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medcare Saglik Urunleri Sanayi 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 “Medcare”

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

Medcare Products 20 Medcare Custom Packaging, Inc. 11 Medcare Medical Group, Inc. 8 Medcare Disp Products, Inc. 6 Medcare Flaga 4 Medcare Manufacturing, Inc. 1

Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Medcare”