Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Mitsui ChemicalsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Kulzer, LLC with 38 510(k) clearances. The most recent is a 510(k) clearance dated Mar 11, 2026: Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 11, 2026 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneK260783 · EBF | 510(k) clearances |
| Dec 19, 2025 | iCEM Universal PlusK254063 · EMA | 510(k) clearances |
| Sep 24, 2025 | RetraxilK243910 · MVL | 510(k) clearances |
| Sep 17, 2024 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-activeK240660 · EBF | 510(k) clearances |
| May 23, 2024 | dima Print Teeth & TempK233868 · EBG | 510(k) clearances |
| Sep 7, 2023 | Signum opaque FK230644 · EBF | 510(k) clearances |
| Apr 21, 2022 | Venus Bulk Flow ONEK220605 · EBF | 510(k) clearances |
| Jun 6, 1991 | PALAVIT GLCK904928 · EGD | 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
