Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in GermanyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Leoni AGLabelled 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 Leoni Fiber Optics with 5 device recalls and 1 510(k) clearance. The most recent is a 510(k) clearance dated Apr 2, 2021: LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable.
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.
| Apr 2, 2021 | LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableK201171 · GEX | 510(k) clearances |
| Oct 17, 2018 | Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packagiClass II · A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having c | Device recalls |
| Oct 17, 2018 | Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope PackagiClass II · A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having c | Device recalls |
| Oct 17, 2018 | Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-RT SmartScope Packaging. Class II · A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having c | Device recalls |
| Oct 17, 2018 | Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT SmartScope Packaging. Class II · A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having c | Device recalls |
| Oct 17, 2018 | Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. Class II · A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having c | 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
