Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled 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 14, 2026, FDA's public records list Eximo Medical Ltd. with 8 510(k) clearances. The most recent is a 510(k) clearance dated Apr 10, 2026: Auryon Atherectomy System.
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 10, 2026 | Auryon Atherectomy SystemK260244 · MCW | 510(k) clearances |
| Jun 27, 2024 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingK241553 · MCW | 510(k) clearances |
| Dec 15, 2023 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000)K233668 · MCW | 510(k) clearances |
| Jun 9, 2023 | Auryon Atherectomy SystemK230709 · MCW | 510(k) clearances |
| Sep 26, 2022 | Auryon Atherectomy CathetersK220116 · MCW | 510(k) clearances |
| Jun 9, 2022 | Auryon Atherectomy SystemK221077 · MCW | 510(k) clearances |
| Dec 2, 2020 | Auryon Atherectomy SystemK202835 · MCW | 510(k) clearances |
| Oct 5, 2018 | B-Laser Atherectomy SystemK181642 · MCW | 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
