FDA applicant

Psi Medical Products, Inc.

Norwalk, CT7 decisions1992–19940 recalls

FDA records 7 decisions for Psi Medical Products, Inc. (Norwalk, CT) from 1992 to 1994: 7 510(k) clearances. Most are in product codes KOD (Catheter, Urological) and FFK (Lithotriptor, Electro-Hydraulic). 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 Psi Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Psi Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Psi Medical Products, Inc.

Which product codes does it file in?

What has FDA decided for it lately?