FDA applicant

Gulf Medical Fiberoptics

Oldsmar, FL2 decisions2002–20061 recall

FDA records 2 decisions for Gulf Medical Fiberoptics (Oldsmar, FL) from 2002 to 2006: 2 510(k) clearances. Most are in product codes FST (Light, Surgical, Fiberoptic) and HBI (Illuminator, Fiberoptic, Surgical Field). 1 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Gulf Medical Fiberoptics since 2007.

Recalls per year

1in 2011

2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Gulf Medical Fiberoptics’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.

Gulf Coast Hyperbarics, Inc. 3 Gulf States Airgas 2 Gulf South Research Institute 1 Gulf Coast Medical, Inc. 1 Gulf Medical Technologies, Inc. 1

Gulf Medical Fiberoptics

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Gulf”