510(k) Report

FDA applicant

Tamabio

Tokyo, JP1 decision2025–20250 recalls

FDA records 1 decision for Tamabio (Tokyo, JP) in 2025: 1 510(k) clearance. All are in product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe…). 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, cardiovascular panel, where it files most

How often FDA has decided Tamabio’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Tamabio by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K240775PeriBeam® Pericardial MembraneTamabio · 2025

The one decision as Tamabio →