Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 15, 2026, FDA's public records list Bio-Med USA with 11 510(k) clearances. The most recent is a 510(k) clearance dated Aug 9, 2022: IRIS Pi Q switched Nd YAG laser.
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.
| Aug 9, 2022 | IRIS Pi Q switched Nd YAG laserK221789 · GEX | 510(k) clearances |
| Oct 6, 2021 | PicoreK212082 · GEX | 510(k) clearances |
| Nov 2, 2018 | Cellene CO2 Laser SystemK182270 · GEX | 510(k) clearances |
| May 15, 2017 | Dental 5 Multi Diode laserK163638 · GEX | 510(k) clearances |
| Mar 20, 2015 | BT-400K142332 · LBI | 510(k) clearances |
| Sep 24, 2014 | LUCID LYK140837 · GEX | 510(k) clearances |
| Jun 6, 2014 | ATOVENK133774 · GEX | 510(k) clearances |
| May 9, 2013 | UNITOX BOTOX SYRINGEK123710 · FMF | 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
