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 Primrose Medical, Inc. with 14 510(k) clearances. The most recent is a 510(k) clearance dated Sep 29, 1989: COLONIC BALLOON DIALATORS.
| Sep 29, 1989 | COLONIC BALLOON DIALATORSK884713 · FFP | 510(k) clearances |
| Sep 29, 1989 | URETHRAL AND URETERAL BALLOON DILATATORSK884711 · EZN | 510(k) clearances |
| Sep 29, 1989 | ACHELASIA BALLOON DIALATORK884715 · KNQ | 510(k) clearances |
| Sep 29, 1989 | BILIARY DIALATORK884714 · FGE | 510(k) clearances |
| Sep 8, 1989 | ESOPHAGEAL AND PYLORIC BALLOON DIALATORSK884712 · KNQ | 510(k) clearances |
| Sep 8, 1989 | ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)K884709 · ODD | 510(k) clearances |
| Aug 26, 1988 | LANCET, BLOODK883420 · FMK | 510(k) clearances |
| Aug 4, 1988 | CATHETER, INTRAVASCULARK881976 · FOZ | 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