Eximo Medical, Ltd. is one of 267 FDA 510(k) medical device manufacturers from Israel in the dataset, ranked by real submission volume.
Eximo Medical, Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Auryon Atherectomy Catheter 1.7mm, 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), Auryon Atherectomy System
7
Total
7
Cleared
0
Denied
Eximo Medical, Ltd. has 7 FDA 510(k) cleared medical devices. Based in Rehovot, IL.
Latest FDA clearance: Jun 2024. Active since 2018. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Eximo Medical, Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Angiodynamics, Hogan Lovells US LLP and AngioDynamics, Inc.. 3 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Eximo Medical, Ltd.
7 devices
Cleared
Jun 27, 2024
Auryon Atherectomy Catheter 1.7mm
Cardiovascular
27d
Cleared
Dec 15, 2023
Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000),...
Cardiovascular
30d
Cleared
Jun 09, 2023
Auryon Atherectomy System
Cardiovascular
87d
Cleared
Sep 26, 2022
Auryon Atherectomy Catheters
Cardiovascular
255d
Cleared
CT
Jun 09, 2022
Auryon Atherectomy System
Cardiovascular
58d
Cleared
CT
Dec 02, 2020
Auryon Atherectomy System
Cardiovascular
68d
Cleared
CT
Oct 05, 2018
B-Laser Atherectomy System
Cardiovascular
106d