FDA applicant

Brixton Biosciences

Cambridge, MA1 decision2026–20260 recalls

FDA records 1 decision for Brixton Biosciences (Cambridge, MA) in 2026: 1 De Novo grant. All are in product code SJA (Injectable For Thermal Treatment Of…). 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 Brixton Biosciences’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

Planning a device like Brixton Biosciences’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

Brixton Biosciences

Which product codes does it file in?

What has FDA decided for it lately?