FDA applicant
Omni Life Science, Inc.
FDA records 21 decisions for Omni Life Science, Inc. (East Taunton, MA) from 2006 to 2019: 21 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and LPH (Prosthesis, Hip, Semi-Constrained…). Its devices cite 63 predicates, 17 of them its own earlier devices. 36 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Omni Life Science, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Omni Life Science, 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.