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1303054

Onyx Medical, LLC dba Elos Medtech — FEI 1043653

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 13, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Bartlett, TN (United States)

Facility

Other inspections at this facility

  • 1169394 (NAI Thu Apr 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015584 (VAI Fri Jun 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 768808 (VAI Mon Feb 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 555083 (NAI Tue Dec 30 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
23019ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes