FDA.reportPublic FDA data

GALIL MEDICAL INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30044624903004462490GALIL MEDICAL INC.1Y2020-04-254364 Round Lake Road Arden Hills MN US 55112

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
00859019006318Visual-ICE MRI Cryoablation Console - MRI Cryoablation System Console651-287-5000galil.cst@btgplc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2338791888807604K181153ICEfx Cryoablation SystemGEH2018-05-15
2338791950993291K173037Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection PanelGEH2017-11-21
2338791977621081K113860VISUAL-ICE CRYOABLATION SYSTEMGEH2012-03-12

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEH32018-05-15

PMN#

ISIS

2007-03-20

GALIL MEDICAL LTD.

GUDID#

60 records. Showing 1-40. Next