Diagnostics 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 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Visby Medical with 5 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated May 27, 2026: Visby Medical Flu and COVID-19 Test.
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.
| May 27, 2026 | Visby Medical Flu and COVID-19 TestK253971 · SIA | 510(k) clearances |
| Oct 1, 2025 | Visby Medical Men's Sexual Health TestK251501 · QEP | 510(k) clearances |
| Mar 28, 2025 | Visby Medical Women's Sexual Health TestDEN240020 · SEA | 510(k) clearances |
| Feb 19, 2025 | Visby Medical Respiratory Health TestK242526 · QOF | 510(k) clearances |
| Mar 7, 2023 | Visby Medical Sexual Health TestK220407 · QEP | 510(k) clearances |
| Aug 26, 2021 | Visby Medical Sexual HealthK200748 · QEP | 510(k) clearances |
| Dec 5, 2020 | visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COClass II · Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. | Device recalls |
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
