Medical device makerLabelled 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 13, 2026, FDA's public records list Visgeneer with 3 510(k) clearances, 2 device recalls and 1 warning letter. The most recent is a warning letter dated Jun 13, 2025: Warning letter: Complaint handling, MDR reporting, Design controls.
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.
| Date | Record | Source |
|---|---|---|
| Jun 13, 2025 | Warning letter: Complaint handling, MDR reporting, Design controlsCDRH | Warning letters |
| Oct 4, 2023 | Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottleClass II · Due to products distributed without premarket clearance or approvals. | Device recalls |
| Oct 4, 2023 | Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottleClass II · Due to products distributed without premarket clearance or approvals. | Device recalls |
| Aug 15, 2013 | EBCHEK BLOOD GLUCOSE MONITORING SYSTEMK122181 · NBW | 510(k) clearances |
| Jan 19, 2010 | EBCARRYON BLOOD GLUCOSE MONITORING SYSTEMK091765 · NBW | 510(k) clearances |
| Dec 27, 2006 | EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-GK062555 · NBW | 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
