FDA.reportPublic FDA data

EXIMO MEDICAL LTD

Matched from indexed company URL: Eximo Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30144437473014443747EXIMO MEDICAL LTD1N2026-01-01Pekeris St. 3 Rehovot Central IL 7670203

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07290017590110Auryon Laser System 100-120 Vac - EXM-2001-11001(800)772-6446customerservice@angiodynamics.com
07290017590172Auryon Atherectomy Catheter - Catheter Eximo Atherectomy 2.35mm - Hydrophilic Coated518-795-1676dgreer@angiodynamics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2230411695276971K260244Auryon Atherectomy SystemMCW2026-04-10
2230412019874033K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingMCW2024-06-27
2230411354271202K233668Auryon 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)MCW2023-12-15
2230411076737079K230709Auryon Atherectomy SystemMCW2023-06-09
2230411373865511K221077Auryon Atherectomy SystemMCW2022-06-09
2230411457379899K220116Auryon Atherectomy CathetersMCW2022-09-26
2230411035757538K202835Auryon Atherectomy SystemMCW2020-12-02
2230411740096283K181642B-Laser Atherectomy SystemMCW2018-10-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MCW82026-04-10

PMN#

GUDID#