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Warning Letter

Case 712573 — FEI 3013450937

Facility

Recent inspections

  • 1167272 (NAI Fri Apr 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1123236 (NAI Tue Dec 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1022148 (NAI Wed Jun 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Onkos Surgical, Inc.
Date
July 21, 2025
Fiscal Year
2025
Product Type
Devices
Center
CDRH
Location
Parsippany, NJ (United States)