Data / Medical devices / Israel / Eximo Medical Ltd
Eximo Medical Ltd: FDA-registered device maker in Rehovot Central, Israel, 8 510(k) clearances
Eximo Medical Ltd is registered with the FDA (registration 3014443747) in Rehovot Central, Israel. It lists 1 device type. The FDA files 8 510(k) clearances under its listings, the newest dated April 10, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014443747
- Address
- Pekeris St. 3, Rehovot Central, Israel, 7670203
- Owner or operator
- AngioDynamics (10058638)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- October 17, 2018
- Registered through
- 2026
- Brand names listed
- AURYON ATHERECTOMY CATHETER 0.9 MM OTW, AURYON ATHERECTOMY CATHETER 1.5 MM OTW, AURYON ATHERECTOMY CATHETER 1.7 MM OTW, AURYON ATHERECTOMY CATHETER 1.7 MM OTW - Hydrophilic Coated, AURYON ATHERECTOMY CATHETER 2 MM OTW, AURYON ATHERECTOMY CATHETER 2.35 MM OTW, Auryon Atherectomy Catheter 0.9mm - Hydrophilic Coated, Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Peripheral, Atherectomy | MCW | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 10, 2026 | K260244 | Auryon Atherectomy System | MCW | Substantially Equivalent | Eximo Medical | accessdata.fda.gov |
| June 27, 2024 | K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating | MCW | Substantially Equivalent | Eximo Medical, Ltd. | accessdata.fda.gov |
| December 15, 2023 | K233668 | 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) | MCW | Substantially Equivalent | Eximo Medical, Ltd. | accessdata.fda.gov |
| June 9, 2023 | K230709 | Auryon Atherectomy System | MCW | Substantially Equivalent | Eximo Medical, Ltd. | accessdata.fda.gov |
| September 26, 2022 | K220116 | Auryon Atherectomy Catheters | MCW | Substantially Equivalent | Eximo Medical, Ltd. | accessdata.fda.gov |
| June 9, 2022 | K221077 | Auryon Atherectomy System | MCW | Substantially Equivalent | Eximo Medical, Ltd. | accessdata.fda.gov |
| December 2, 2020 | K202835 | Auryon Atherectomy System | MCW | Substantially Equivalent | Eximo Medical, Ltd. | accessdata.fda.gov |
| October 5, 2018 | K181642 | B-Laser Atherectomy System | MCW | Substantially Equivalent | Eximo Medical, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated April 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.