Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA files no records under this name; these are its 4 companies' records, each linked to the record.
As of Nov 15, 2026, FDA's public records list OSI Systems and its 4 subsidiaries with 89 510(k) clearances and 9 device recalls. The most recent is a device recall dated May 22, 2015: American Science & Engineering Inc,Gemini Cabinet X-ray system..
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, OSI Systems and its 4 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 22, 2015 | American Science & Engineering Inc,Gemini Cabinet X-ray system.Class II · During factory testing, we discovered that Gemini systems could, in rare circumstances, experience a fault that leads to | Device recalls |
| Mar 29, 2012 | SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390K120616 · MHX | 510(k) clearances |
| Nov 2, 2011 | SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)K112962 · MHX | 510(k) clearances |
| Dec 7, 2010 | SPACELABS MEDICAL PATIENT MONITORSK102422 · MHX | 510(k) clearances |
| Nov 24, 2009 | ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATIONK093501 · MHX | 510(k) clearances |
| Aug 1, 2008 | MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220K082045 · MHX | 510(k) clearances |
| Mar 15, 2007 | SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810K063490 · DQK | 510(k) clearances |
| Jan 25, 2007 | SENTINELK062397 · DXH | 510(k) clearances |
| Nov 3, 2006 | VOYAGER 12K062469 · DPS | 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
