510(k) Report

FDA applicant

Goosen Enterprises, Inc.

Goldenrod, FL4 decisions1985–19940 recalls

FDA records 4 decisions for Goosen Enterprises, Inc. (Goldenrod, FL) from 1985 to 1994: 4 510(k) clearances. Most are in product codes EZD (Catheter, Straight) and GCX (Apparatus, Suction, Operating-Room, Wall…). 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 Goosen Enterprises, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Goosen Enterprises, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Goosen Enterprises, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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