FDA applicant
Omega Medical Electronics
FDA records 21 decisions for Omega Medical Electronics (Mchenry, IL) from 1982 to 1983: 21 510(k) clearances. Most are in product codes CFJ (Nad Reduction/Nadh Oxidation, Lactate…) and CHD (Acid, Ferric Ion-Sulfuric, Cholesterol). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Omega Medical Electronics’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Omega Medical Electronics since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Omega Medical Electronics’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) ReportOther applicant names beginning “Omega”
FDA records each applicant name separately; these may or may not be the same firm.