FDA applicant

TransMedics, Inc.

Andover, MA6 decisions2018–20230 recalls

FDA records 6 decisions for TransMedics, Inc. (Andover, MA) from 2018 to 2023: 3 510(k) clearances and 3 original PMA approvals. Most are in product codes MSB (System And Accessories, Isolated Heart…) and DTM (Filter, Blood, Cardiopulmonary Bypass…). Its devices cite 3 predicates, 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2023

2018high 3 (2021) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

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

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TransMedics, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?