510(k) Report

FDA applicant

Omega Universal Technologies, Ltd.

Marlboro, NJ3 decisions1991–19930 recalls

FDA records 3 decisions for Omega Universal Technologies, Ltd. (Marlboro, NJ) from 1991 to 1993: 3 510(k) clearances. Most are in product codes LYK (Angioscope) and EOB (Nasopharyngoscope (Flexible Or Rigid)). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Omega Universal Technologies, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Omega Universal Technologies, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Omega Universal Technologies, Ltd.’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

Other applicant names beginning “Omega”

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