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 13, 2026, FDA's public records list Cefla and its 2 subsidiaries with 27 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated May 4, 2026: Neowise.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Cefla and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| May 4, 2026 | NeowiseK260716 · LLZ | 510(k) clearances |
| Mar 10, 2026 | myray ProXIma X6K252353 · OAS | 510(k) clearances |
| Apr 1, 2024 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,K230895 · EBW | 510(k) clearances |
| Feb 13, 2024 | Apex LocatorK231990 · LQY | 510(k) clearances |
| Jan 17, 2023 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSK223794 · OAS | 510(k) clearances |
| May 9, 2022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LEDK213022 · EBW | 510(k) clearances |
| May 6, 2022 | NewTom 7GK220664 · JAK | 510(k) clearances |
| Jan 20, 2022 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSK214084 · OAS | 510(k) clearances |
| Aug 10, 2012 | MyRay RXDC dental unit x-ray unitClass II · The RX DC dental x-ray unit was found to be noncompliant with 21CFR 1010,2, 1020.30(e) & 1020.30(h). Specifically, 1. | Device recalls |
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
