FDA.reportPublic FDA data

EXIMO MEDICAL LTD

Matched from indexed company URL: Eximo Medical, Ltd.

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
072900175900041.5 mm OTW B-Laser™ catheter - 1.5 mm OTW B-Laser™ catheter For Infra Inguinal Atherectomy1-480-213-8499roberts@eximomedical.com
072900175900110.9 mm OTW B-Laser™ catheter - 0.9 mm OTW B-Laser™ catheter For Infra Inguinal Atherectomy1-480-213-8499roberts@eximomedical.com
072900175900282.0 mm OTW B-Laser™ catheter - 2.0 mm OTW B-Laser™ catheter For Infra Inguinal Atherectomy1-480-213-8499roberts@eximomedical.com
072900175900352.35 mm OTW B-Laser™ catheter - 2.35 mm OTW B-Laser™ catheter For Infra Inguinal Atherectomy1-480-213-8499roberts@eximomedical.com
07290017590042Laser system - 200-240 Vac Laser system For Infra Inguinal Atherectomy1-480-213-8499roberts@eximomedical.com
07290017590059Laser system - 100-120 Vac Laser system For Infra Inguinal Atherectomy1-480-213-8499roberts@eximomedical.com
07290017590325Auryon Atherectomy Catheter - Auryon Atherectomy Catheter 1.7mm - Hydrophilic Coated+1(800)772-6446customerservice@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#