Medical device makerLabelled 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.
As of Nov 15, 2026, FDA's public records list Ihara Medics U.S. with 5 510(k) clearances. The most recent is a 510(k) clearance dated May 2, 1996: KETOREX C SANWA.
| May 2, 1996 | KETOREX C SANWAK953452 · JMK | 510(k) clearances |
| Jul 1, 1991 | KETO-340 IIK912373 · JIN | 510(k) clearances |
| Dec 20, 1990 | KETOREX SANWA STANDARDSK903365 · JIN | 510(k) clearances |
| Nov 20, 1990 | KETONE TEST A SANWA STANDARDK903367 · JIN | 510(k) clearances |
| Nov 20, 1990 | KETONE TEST B SANWA STANDARDK903366 · JIN | 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
