Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Omni Life Science with 21 510(k) clearances and 7 device recalls. The most recent is a 510(k) clearance dated Sep 25, 2019: OMNI TiN Coated Apex Knee™ System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 25, 2019 | OMNI TiN Coated Apex Knee™ SystemK191765 · JWH | 510(k) clearances |
| Oct 14, 2016 | OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use duriClass III · Incorrect lot number on outer kit | Device recalls |
| Mar 10, 2016 | OMNI Skirted HeadsK152919 · LZO | 510(k) clearances |
| Oct 8, 2013 | APEX KNEE MODULAR TIBIA SYSTEMK131472 · JWH | 510(k) clearances |
| Feb 29, 2012 | APEX REVISION KNEE SYSTEMSK112891 · JWH | 510(k) clearances |
| Jan 5, 2012 | APEX ARC HIP STEMK113242 · LPH | 510(k) clearances |
| Jul 13, 2011 | APEX KNEE SYSTEM, APEX ALL POLY TIBIAK111062 · JWH | 510(k) clearances |
| Jun 27, 2011 | APEX ARC HIP STEMK111193 · LZO | 510(k) clearances |
| Jun 22, 2011 | APEX PS KNEE SYSTEM - PS-C INSERTK111184 · JWH | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
