FDA applicant

Eastern Breeze Intl. Co.

Miami, FL1 decision1994–19940 recalls

FDA records 1 decision for Eastern Breeze Intl. Co. (Miami, FL) in 1994: 1 510(k) clearance. All are in product code HQY (Sunglasses (Non-Prescription Including…). 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, ophthalmic panel, where it files most

How often FDA has decided Eastern Breeze Intl. Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eastern Breeze Intl. Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eastern Breeze Intl. Co. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Eastern”

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

Eastern Anesthesia, Inc. 2 Eastern Cranial Affiliates, LLC 2 Eastern Laboratories, Ltd. 2 Eastern Medikit, Ltd. 1 Eastern Corp. 1

Eastern Breeze Intl. Co.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Eastern”