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.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Emed Technologies with 11 510(k) clearances. The most recent is a 510(k) clearance dated Dec 22, 2025: Tetra (TM-20); Tetra (TM-50).
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.
| Date | Record | Source |
|---|---|---|
| Dec 22, 2025 | Tetra (TM-20); Tetra (TM-50)K251105 · PKP | 510(k) clearances |
| Feb 16, 2024 | SCIg60 Infusion SystemK240148 · PKP | 510(k) clearances |
| Nov 28, 2023 | VersaPump Infusion SystemK230883 · PKP | 510(k) clearances |
| Oct 20, 2022 | AccuSert Needle InserterK213429 · KZH | 510(k) clearances |
| Oct 13, 2022 | SCIg60 Infusion SystemK222087 · PKP | 510(k) clearances |
| Dec 14, 2018 | SCIg60 Infusion SystemK173783 · PKP | 510(k) clearances |
| Dec 1, 2016 | SCIg60 InfuserK161906 · PKP | 510(k) clearances |
| May 14, 2015 | SCIg60 Infuser, InfusetK142319 · PKP | 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
