FDA applicant

Marian Medical, Inc.

Louisville, KY4 decisions2005–20070 recalls

FDA records 4 decisions for Marian Medical, Inc. (Louisville, KY) from 2005 to 2007: 4 510(k) clearances. Most are in product codes GBM (Catheter, Urethral) and LJS (Catheter, Intravascular, Therapeutic…). 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 Marian Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Marian Medical, Inc.

Which product codes does it file in?

What has FDA decided for it lately?