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 Epcom Medical Systems with 13 510(k) clearances. The most recent is a 510(k) clearance dated May 9, 1991: GLOVE-N-GEL AMNIOTOMY KIT.
| May 9, 1991 | GLOVE-N-GEL AMNIOTOMY KITK910518 · HGE | 510(k) clearances |
| Jan 31, 1991 | INTRAUTERINE CATHETER SETK905812 · HGS | 510(k) clearances |
| Jun 14, 1988 | CERVICATHK881414 · HDR | 510(k) clearances |
| Jul 13, 1987 | FETALFLEX FETAL ELECTRODEK871079 · HGP | 510(k) clearances |
| Feb 25, 1985 | 1URO-LOG HOME DIAGNOSTIC PACKK844338 · FFG | 510(k) clearances |
| Jan 2, 1985 | UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACKK844503 · FAP | 510(k) clearances |
| Jun 19, 1984 | OBSTETRICAL DOPPLERK841805 · KNG | 510(k) clearances |
| Aug 12, 1983 | EPCOM EMS-310 INTRAPARTUM MONITORK831113 · HGM | 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