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 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Somnomedics GmbH with 8 510(k) clearances. The most recent is a 510(k) clearance dated Dec 8, 2024: HomeSleepTest (HST, HST REM+).
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.
| Dec 8, 2024 | HomeSleepTest (HST, HST REM+)K240700 · OLV | 510(k) clearances |
| Nov 27, 2023 | ABPMproK231104 · DSH | 510(k) clearances |
| Jun 15, 2022 | EEG-acpK212325 · GYB | 510(k) clearances |
| Aug 12, 2020 | SOMNOscreen plusK201054 · OLV | 510(k) clearances |
| Jan 30, 2015 | SOMNOTOUCH RESPK140861 · MNR | 510(k) clearances |
| Sep 18, 2008 | SOMNOWATCHK081485 · MNR | 510(k) clearances |
| Jul 18, 2007 | SOMNOSCREEN EEG10-20K071556 · MNR | 510(k) clearances |
| Jan 24, 2007 | SOMNOSCREENK060708 · MNR | 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
