FDA applicant

Fossa Medical, Inc.

Boston, MA3 decisions2003–20080 recalls

FDA records 3 decisions for Fossa Medical, Inc. (Boston, MA) from 2003 to 2008: 3 510(k) clearances. Most are in product codes FAD (Stent, Ureteral) and EYB (Catheter, Ureteral, Gastro-Urology). Its devices cite 5 predicates, 2 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 Fossa Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Fossa Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fossa Medical, 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

Other applicant names beginning “Fossa”

FDA records each applicant name separately; these may or may not be the same firm.

Fossa Industries, Inc. 2

Fossa Medical, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Fossa”