FDA applicant

TELA Bio, Inc.

Malvern, PA5 decisions2014–20260 recalls

FDA records 5 decisions for TELA Bio, Inc. (Malvern, PA) from 2014 to 2026: 5 510(k) clearances. Most are in product codes FTM (Mesh, Surgical) and FTL (Mesh, Surgical, Polymeric). Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Tela Bio”.

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 TELA Bio, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2014high 2 (2024) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — TELA Bio, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like TELA Bio, Inc.’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

TELA Bio, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?