Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SingaporeLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Biobot Surgical with 7 510(k) clearances. The most recent is a 510(k) clearance dated Dec 21, 2023: iSR`obot Mona Lisa 2.0.
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.
| Dec 21, 2023 | iSR`obot Mona Lisa 2.0K232320 · IYO | 510(k) clearances |
| Dec 22, 2021 | iSR’obot Mona Lisa 2.0K213411 · IYO | 510(k) clearances |
| Jul 8, 2021 | iSR'obot Mona Lisa 1.0K203659 · IYO | 510(k) clearances |
| May 16, 2017 | iSR'obot Biopsy KitK163502 · ITX | 510(k) clearances |
| Oct 6, 2016 | iSR'obot MRI-US FusionK161109 · LLZ | 510(k) clearances |
| Jun 7, 2013 | ISR'OBOT MONA LISAK130944 · IYO | 510(k) clearances |
| Aug 12, 2011 | ISROBOT MONA LISAK111347 · IYO | 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
