Eximo Medical Ltd
Rehovot Central, IL
EXIMO MEDICAL LTD appears in FDA device records in Rehovot Central, IL. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Eximo Medical Ltd between 2018 and 2026. The busiest year on record is 2022, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260244 | Auryon Atherectomy System | MCW | Substantially Equivalent | |
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating | MCW | Substantially Equivalent | |
| 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 | |
| K230709 | Auryon Atherectomy System | MCW | Substantially Equivalent | |
| K220116 | Auryon Atherectomy Catheters | MCW | Substantially Equivalent | |
| K221077 | Auryon Atherectomy System | MCW | Substantially Equivalent | |
| K202835 | Auryon Atherectomy System | MCW | Substantially Equivalent | |
| K181642 | B-Laser Atherectomy System | MCW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014443747 | 3014443747 | EXIMO MEDICAL LTD | Pekeris St. 3, Rehovot Central 7670203 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain