FDA applicant
Omi Manufacturing Pty., Ltd.
FDA records 2 decisions for Omi Manufacturing Pty., Ltd. (Deer Field, IL) from 2003 to 2006: 2 510(k) clearances. Most are in product codes GES (Blade, Scalpel) and MEG (Syringe, Antistick). Its devices cite 3 predicates, 0 of them its own earlier devices. 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 Omi Manufacturing Pty., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Omi Manufacturing Pty., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Omi Manufacturing Pty., Ltd.’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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