510(k) Report

FDA applicant

Omega Medical Corp.

Clearwater, FL2 decisions1987–19880 recalls

FDA records 2 decisions for Omega Medical Corp. (Clearwater, FL) from 1987 to 1988: 2 510(k) clearances. All are in product code FLL (Continuous Measurement Thermometer). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Omega Medical Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Omega”

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