FDA applicant
Omni Intl., Inc.
FDA records 12 decisions for Omni Intl., Inc. (Palm Springs, CA) from 1982 to 1999: 12 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and FPA (Set, Administration, Intravascular). 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 Omni Intl., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Omni Intl., Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Omni Intl., Inc.’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 “Omni”
FDA records each applicant name separately; these may or may not be the same firm.