Roche
Diagnostics makerAI in SwitzerlandAI. FDA records under 2 spellings of its name, each linked to the record. See the Roche group view.
- Records across the group: 1,461, 26 entitiesAI
- 510(k) clearances: 1,041
- Device recalls: 290
- Drug applications: 116
- Drug recalls: 12
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Roche and its 25 subsidiaries
Latest Records
Newest first across sources; each opens the recordSubsidiaries and Divisions
25 firms in the Roche group, most records first- Roche Diagnostics498 records
- Roche Diagnostics Systems296 records
- Roche Diagnostics Operations, Inc.148 records
- Roche Molecular Systems95 records
- Ventana Medical Systems89 records
- Hoffmann-La Roche61 records
- Genentech54 records
- Roche Diabetes Care42 records
- Disetronic Medical Systems29 records
- Biotrack16 records
- Roche Medical Electronics, Inc.16 records
- Roche Palo Alto13 records
- Roche Analytical Instruments11 records
- Foundation Medicine10 records
- Syntex Corp.10 records
- GenMark Diagnostics, Inc.9 records
- Roche Diagnostics / Boehringer Mannheim GmbH3 records
- Medingo Ltd.2 records
- Roche Diagnostics Hematology2 records
- Roche Professional Diagnostics2 records
- F. Hoffmann-La Roche1 records
- Hoffman-La Roche1 records
- Roche Image Analysis Systems1 records
- Roche Scientific Corp.1 records
- Roche Tissue Diagnostics1 records
Roche DiagnosticsCanada and Imports
Across the Roche group, matched by company nameNames and Identifiers
- Appears as
- Website
- roche.com
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