Medical device makerLabelled 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 Baui Biotech with 5 510(k) clearances. The most recent is a 510(k) clearance dated Oct 17, 2024: NOVA Minimally Invasive System.
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.
| Oct 17, 2024 | NOVA Minimally Invasive SystemK242899 · NKB | 510(k) clearances |
| Apr 14, 2020 | COMET Lumbar Interbody Fusion CageK191353 · MAX | 510(k) clearances |
| Aug 12, 2019 | Facilis™ Spinal SystemK191494 · NKB | 510(k) clearances |
| Jun 11, 2019 | NOVA Minimally Invasive SystemK182416 · NKB | 510(k) clearances |
| Jan 23, 2017 | Facilis™ Spinal SystemK161231 · NKB | 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
