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 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Delta Med SpA with 11 device recalls and 4 510(k) clearances. The most recent is a device recall dated Jun 21, 2021: NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units.
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.
| Jun 21, 2021 | NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 unitsClass II · Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Device recalls |
| Jun 21, 2021 | NEO DELTA Self Safe, I.V. Catheter REF 3738222Class II · Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Device recalls |
| Jun 21, 2021 | NEO DELTA SELFSAFE PUR T, I.V. Catheter:Class II · Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Device recalls |
| Jun 21, 2021 | NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522Class II · Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Device recalls |
| Jun 21, 2021 | DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831Class II · Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Device recalls |
| Jun 21, 2021 | NEO DELTA SELFSAFE PUR T, I.V. Catheter: a) REF 3738522 b) REF 3738822Class II · Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Device recalls |
| Jun 21, 2021 | WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475WClass II · Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Device recalls |
| Jun 21, 2021 | DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272Class II · Problems related to the sterilization of the medical devices; possible missing sterility of the medical device | Device recalls |
| Aug 26, 2020 | Deltaven Fast Flash Closed I.V. Catheter SystemsK200373 · FOZ | 510(k) clearances |
| Dec 21, 2017 | Deltaven XiV Max, Deltaven XiV Max FFK171530 · FOZ | 510(k) clearances |
| Aug 5, 2014 | INTRAVASCULAR ADMINISTRATION SETK140175 · FPA | 510(k) clearances |
| Dec 28, 2012 | NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1K121007 · 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
