Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwitzerlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Medimaps Group with 3 510(k) clearances and 2 device recalls. The most recent is a device recall dated Feb 3, 2025: Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x….
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.
| Feb 3, 2025 | Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, Class II · Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon ma | Device recalls |
| Jan 17, 2025 | TBS iNsight (V4)K243218 · KGI | 510(k) clearances |
| Oct 3, 2016 | TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysisClass II · The FRAX adjusted for TBS values are not correct when: The FRAX feature is activated in TBS iNsight; and TBS has been co | Device recalls |
| Apr 29, 2016 | TBS iNsightK152299 · KGI | 510(k) clearances |
| Oct 5, 2012 | TBS INSIGHTK121716 · KGI | 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
