510(k) Report

FDA applicant

Shanghai Medi Astro Technology Co., Ltd.

Shanghai, CN1 decision2026–20260 recalls

FDA records 1 decision for Shanghai Medi Astro Technology Co., Ltd. (Shanghai, CN) in 2026: 1 510(k) clearance. All are in product code ETA (Replacement, Ossicular Prosthesis, Total). 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 Shanghai Medi Astro Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026 (partial year): 1
2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

FIG. 1 — Shanghai Medi Astro Technology Co., Ltd. by year, 2026–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ETAReplacement, Ossicular Prosthesis, Total1decision

What has FDA decided for it lately?

  • K260264Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)Shanghai Medi Astro Technology Co., Ltd. · 2026

The one decision as Shanghai Medi Astro Technology Co., Ltd. →