Pharmaceutical companyLabelled 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., part of RocheLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record. See the Roche group view.
As of Nov 13, 2026, FDA's public records list Syntex Corp. with 10 510(k) clearances. The most recent is a 510(k) clearance dated Apr 17, 1992: TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION).
| Date | Record | Source |
|---|---|---|
| Apr 17, 1992 | TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION)K920314 · DIS | 510(k) clearances |
| Oct 24, 1984 | SURGIPRESS SURGICAL LOOPK843593 · HRQ | 510(k) clearances |
| Jul 27, 1978 | AMALGAM ALLOYK780997 · EJJ | 510(k) clearances |
| Jun 2, 1978 | S-100 CT SCANNERK780769 · JAK | 510(k) clearances |
| Apr 28, 1978 | FIBER OPTIC HANDPIECEK780483 · EFB | 510(k) clearances |
| Jan 3, 1977 | OPUS I OPTION - FIBER OPTIC L SYSTEMK761331 · EAY | 510(k) clearances |
| Dec 30, 1976 | SYNTEX SYSTEM 6000K761330 · JAK | 510(k) clearances |
| Dec 30, 1976 | HI-SENSITIVITY MODE OPTION FOR S60-1AK761332 · JAK | 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
