510(k) Report

FDA applicant

Gulf Coast Medical, Inc.

Oldsmar, FL1 decision1990–19900 recalls

FDA records 1 decision for Gulf Coast Medical, Inc. (Oldsmar, FL) in 1990: 1 510(k) clearance. All are in product code EFQ (Gauze/Sponge, Internal). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Gulf Coast Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gulf Coast Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Gulf Coast Medical, 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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Other applicant names beginning “Gulf”

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