FDA.reportPublic FDA data

MONTERIS MEDICAL CORP

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30099700703009970070MONTERIS MEDICAL CORP1N2026-01-01131 Cheshire Lane, Suite 100 Minnetonka MN US 55305

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1491421191120935K240877Monteris Medical NeuroBlate SystemONO2024-06-04
1491421252271814K231061NeuroBlate SystemGEX2023-12-08
1491421361805310K222983NeuroBlate Fusion-S Software V3.17GEX2023-03-15
1491421762077746K201056NeuroBlate SystemGEX2020-08-21
1491421056111699K193375NeuroBlate SystemGEX2020-01-03
1491421085612714K182036NeuroBlate SystemGEX2018-10-15
1491421884255698K173305NeuroBlate SystemGEX2017-11-17
1491421583325955K172881NeuroBlate SystemGEX2017-10-20
1491421170586512K171255Monteris Medical NeuroBlate SystemGEX2017-07-25
1491421496603715K170724NeuroBlate SystemGEX2017-04-07
1491421554215733K162762NeuroBlate SystemGEX2016-10-26
1491421795315730K143457NeuroBlate SystemGEX2015-02-19
1491421717006921K141983NEUROBLATE SYSTEMGEX2014-08-11
1491421309180947K132444ATAMA SYSTEMMOS2014-01-27
1491421137512378K131955NEUROBLATE(TM) SYSTEMGEX2013-07-30
1491421497591105K131278MONTERIS MEDICAL NEUROBLATE SYSTEMGEX2013-07-11
1491421983860829K120561NEUROBLATE SYSTEMGEX2013-04-01
1491421440343450K110411ATAMA SYSTEMMOS2011-04-08
1491421759791872K090240MONTERIS MEDICAL UFOHAW2009-08-06
1491421560360579K081509MONTERIS MEDICAL AUTOLITT LASER PROBEGEX2009-05-01
1491421741952309K030172SMALL HIGH SPEED MOTOR DRILL SYSTEMHBE2003-04-03
1491421256387652
1491421313722447

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX162023-12-08
MOS22014-01-27
ONO12024-06-04
HAW12009-08-06
HBE12003-04-03

PMN#