Company ยท IL
Eximo Medical, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2026. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | 8 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 10, 2026 | K260244 | Auryon Atherectomy System Eximo Medical, IL | MCW |
| Jun 27, 2024 | K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating Eximo Medical, Ltd., IL | MCW |
| Dec 15, 2023 | K233668 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydro Eximo Medical, Ltd., IL | MCW |
| Jun 9, 2023 | K230709 | Auryon Atherectomy System Eximo Medical, Ltd., IL | MCW |
| Sep 26, 2022 | K220116 | Auryon Atherectomy Catheters Eximo Medical, Ltd., IL | MCW |
| Jun 9, 2022 | K221077 | Auryon Atherectomy System Eximo Medical, Ltd., IL | MCW |
| Dec 2, 2020 | K202835 | Auryon Atherectomy System Eximo Medical, Ltd., IL | MCW |
| Oct 5, 2018 | K181642 | B-Laser Atherectomy System Eximo Medical, Ltd., IL | MCW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||