Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in NetherlandsLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of ElektaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Nucletron with 61 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Jul 24, 2026: LumenCare Azure.
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.
| Jul 24, 2026 | LumenCare AzureK262383 · JAQ | 510(k) clearances |
| Dec 19, 2025 | Rectal ApplicatorK251037 · JAQ | 510(k) clearances |
| Jan 11, 2022 | EsteyaK213942 · JAD | 510(k) clearances |
| Jul 16, 2020 | GenevaK201272 · JAQ | 510(k) clearances |
| Nov 18, 2019 | There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. DuClass II · A component failure may lead to treatment interruption or incorrect source positioning. | Device recalls |
| Aug 10, 2017 | Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning sofClass II · Incorrect source step size may occur in the software plans | Device recalls |
| Jan 27, 2017 | Advanced Gynecological ApplicatorK161688 · JAQ | 510(k) clearances |
| Jun 23, 2015 | Henschke Titanium Applicator SetK151272 · JAQ | 510(k) clearances |
| Mar 10, 2015 | Martinez Prostate Template SetK142439 · JAQ | 510(k) clearances |
| Jun 26, 2014 | LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MMK140803 · JAQ | 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
