DistributorLabelled 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 American Imex with 11 510(k) clearances. The most recent is a 510(k) clearance dated Jan 7, 2004: PREMIER PLUS.
| Jan 7, 2004 | PREMIER PLUSK032003 · GZJ | 510(k) clearances |
| Sep 22, 1998 | PREMIER APK982221 · GZJ | 510(k) clearances |
| Jun 1, 1993 | MICROCARE(TM)K926326 · GZJ | 510(k) clearances |
| Nov 22, 1991 | ULTIMA XS, MODIFICATIONK912289 · GZJ | 510(k) clearances |
| Nov 6, 1989 | ULTIMA XS MICROCURRENT TENSK895295 · GZJ | 510(k) clearances |
| Aug 10, 1989 | ZIMMER TENSK894388 · GZJ | 510(k) clearances |
| May 4, 1988 | EASY TENSK881704 · GZJ | 510(k) clearances |
| Apr 11, 1988 | PREMIER 10S (TENS)K881424 · GZJ | 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
