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 Sime Health with 11 510(k) clearances. The most recent is a 510(k) clearance dated Nov 15, 1995: SIME SURGICAL POWDERFREE.
| Nov 15, 1995 | SIME SURGICAL POWDERFREEK954025 · KGO | 510(k) clearances |
| Nov 15, 1995 | SIME POWDERFREE PLUSK954051 · LYY | 510(k) clearances |
| Jun 16, 1995 | AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFIK932985 · HIS | 510(k) clearances |
| Jul 7, 1994 | SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)K932982 · HIS | 510(k) clearances |
| Jul 7, 1994 | UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFIK932984 · HIS | 510(k) clearances |
| Jul 7, 1994 | COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)K932983 · HIS | 510(k) clearances |
| May 9, 1994 | SIME SURGICAL LATEX GLOVEK940797 · KGO | 510(k) clearances |
| Oct 15, 1993 | SIME HEALTH SIME HYPOALLERGENICK931491 · LYY | 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
