Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in MonacoLabelled 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 13, 2026, FDA's public records list Promepla and its 1 subsidiaries with 6 510(k) clearances. The most recent is a 510(k) clearance dated Sep 7, 2018: Bi-Flex Evo.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Promepla and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 7, 2018 | Bi-Flex EvoK182144 · KNY | 510(k) clearances |
| Mar 12, 2018 | RocaJJ Soft StentsK173734 · FAD | 510(k) clearances |
| Feb 9, 2016 | ENDOFLOW II - Irrigation, Warming and Suction SystemK152278 · OCX | 510(k) clearances |
| Jun 17, 2014 | BI-FLEX URETERAL ACCESS SHEATHK140441 · KNY | 510(k) clearances |
| May 14, 2012 | ROCAMED ROCAUS PLATINUMK120160 · KNY | 510(k) clearances |
| Oct 4, 2007 | PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SETK071421 · FPA | 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
