510(k) Report

FDA applicant

Mesoblast

Melbourne1 decision2018–20180 recalls

FDA records 1 decision for Mesoblast (Melbourne) in 2018: 1 original PMA approval. All are in product code MOZ (Acid, Hyaluronic, Intraarticular). 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Mesoblast by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MOZAcid, Hyaluronic, Intraarticular1decision

What has FDA decided for it lately?

The one decision as Mesoblast →