Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list CSD Labs GmbH with 3 510(k) clearances and 3 AI-enabled devices. The most recent is a 510(k) clearance dated Dec 19, 2025: eMurmur Heart AI.
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 |
|---|---|---|
| Dec 19, 2025 | eMurmur Heart AIK252284 · DQD | 510(k) clearances |
| Dec 19, 2025 | eMurmur Heart AIK252284 · Cardiovascular | AI-enabled devices |
| May 31, 2022 | eMurmur Heart AIK220766 · DQD | 510(k) clearances |
| May 31, 2022 | eMurmur Heart AIK220766 · Cardiovascular | AI-enabled devices |
| Apr 17, 2019 | eMurmur IDK181988 · DQD | 510(k) clearances |
| Apr 17, 2019 | eMurmur IDK181988 · Cardiovascular | AI-enabled devices |
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
