Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Roche. FDA records under its name, each linked to the record. See the Roche group view.
As of Nov 15, 2026, FDA's public records list Roche Medical Electronics, Inc. with 16 510(k) clearances. The most recent is a 510(k) clearance dated Nov 21, 1979: ROCHE SENSOR ADAPTOR.
| Nov 21, 1979 | ROCHE SENSOR ADAPTORK791559 · KLK | 510(k) clearances |
| Sep 4, 1979 | FETASONDE FETAL HEART RATE VARIABILITYK791039 · HGM | 510(k) clearances |
| Sep 4, 1979 | FETASONDE FETAL ACTIVITY MONITORK791035 · HGM | 510(k) clearances |
| Sep 4, 1979 | FETASONDE UTERINE ACTIVITY MONITORK791038 · HGM | 510(k) clearances |
| Sep 4, 1979 | FETASONDE UTERINE WORK MONITORK791036 · HGM | 510(k) clearances |
| Sep 4, 1979 | FETASONDE LABOR STATUS DISPLAYK791037 · HGM | 510(k) clearances |
| Jun 1, 1979 | FETASONDE MODEL 2108K790761 · HGM | 510(k) clearances |
| May 15, 1979 | ROCHE LACTATE ANALYZER 640K790421 · KHP | 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
