Medimaps Group

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1250-2025Class IIBrand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBFebruary 3, 2025
Z-0369-2017Class IITBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is instOctober 3, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K243218TBS iNsight (V4)January 17, 2025
K152299TBS iNsightApril 29, 2016
K121716TBS INSIGHTOctober 5, 2012