FDA applicant
Goosen Enterprises, Inc.
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
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.
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.
See the 510(k) Report