Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ItalyLabelled 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 Haemotronic S.p.A. with 6 510(k) clearances. The most recent is a 510(k) clearance dated Aug 19, 2021: Empty EVA Bag.
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.
| Aug 19, 2021 | Empty EVA BagK210749 · KPE | 510(k) clearances |
| Jul 22, 2020 | Empty EVA BagK193528 · KPE | 510(k) clearances |
| Feb 24, 1995 | CAVH/CVVH/CAVHD SET MODEL #HT-HF/505K921597 · FJK | 510(k) clearances |
| Dec 24, 1992 | HAEMOTROL MODEL #HT-SB/6 BURETTE SETK921594 · FPA | 510(k) clearances |
| Dec 24, 1992 | Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2K921595 · BRZ | 510(k) clearances |
| Mar 30, 1992 | DRAIN/PRIMING/RECIRCULATION BAGK913361 · KOC | 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
