Pharmaceutical companyLabelled 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., part of Boston ScientificLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list BTG International with 6 510(k) clearances and 6 drug applications. The most recent is a 510(k) clearance dated Aug 23, 2019: EkoSonic Endovascular Device.
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 23, 2019 | EkoSonic Endovascular DeviceK191119 · QEY | 510(k) clearances |
| Apr 5, 2019 | EkoSonic Endovascular Device with Control Unit 4.0K183361 · QEY | 510(k) clearances |
| Nov 26, 2018 | EkoSonic Endovascular SystemK182324 · QEY | 510(k) clearances |
| Mar 24, 2018 | EKOS ultrasound EVD Device, EVD Control UnitK172035 · JXG | 510(k) clearances |
| Feb 24, 2017 | EkoSonic Endovascular System with Control Unit 4.0K162771 · QEY | 510(k) clearances |
| May 21, 2014 | EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNITK140151 · QEY | 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
