Medical device makerLabelled 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 Koven Technology with 18 510(k) clearances and 1 device recall. The most recent is a device recall dated Mar 4, 2026: Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C feta….
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.
| Mar 4, 2026 | Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BTClass II · Product labeling includes a fetal indication for use that is not cleared under its 510(k). | Device recalls |
| Jan 5, 2021 | Bidop 7K201114 · DPW | 510(k) clearances |
| May 25, 2016 | Smartdop XT6K153762 · JOP | 510(k) clearances |
| Apr 14, 2015 | Fast Sphyg by KovenK143332 · DXQ | 510(k) clearances |
| Jan 17, 2014 | SMARTDOP XTK131623 · JOP | 510(k) clearances |
| Jul 28, 2008 | VALVULOTOME BY KOVENK080178 · MGZ | 510(k) clearances |
| Apr 15, 2005 | SMARTDOP 45 VASCULAR DOPPLERK050601 · DPW | 510(k) clearances |
| Feb 13, 2004 | ECHO SOUNDER EX-101EX 8 MHZK031931 · DPW | 510(k) clearances |
| Jul 18, 2003 | ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EXK031504 · KNG | 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
