INFINIUM MEDICAL, INC.

Matched from indexed company URL: INFINIUM MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10664273007513035INFINIUM MEDICAL, INC.1Y2026-01-0112151 62ND ST., N, UNIT 5 Largo FL US 33773

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1012751259763523K954280
1012751557078306K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound ImagingIYN2024-09-11
1012752002718923K232638FilteredFlo Warming BlanketsDWJ2023-10-24
1012751906474115K231596IOB Temperature Management SystemDWJ2023-06-30
1012751639114061K220138Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HPGEI2022-10-05
1012751382539909K191307Palm Bladder Scanner - PBSV5.1IYO2019-06-05
1012751562586764K142244CLEO PATIENT MONITORMWI2015-02-06
1012751460568283K131790A9800 ANESTHESIA WORKSTATIONBSZ2014-05-09
1012751480598486K113485ELECTROCARDIOGRAPHDPS2012-04-25
1012752002419213K112329OMNI PATIENT MONITORMWI2011-09-08
1012751736745012K103737OMNI II PATIENT MONITORMWI2011-06-02
1012751701918756K103268OMNI EXPRESSMWI2010-11-23
1012751671621975K101052OMNI III PATIENT MONITORMWI2010-08-11
1012752033983286K012446OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRIBSZ2001-10-03
1012751743748971K000859OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1BSZ2000-08-23
1012751001433493
1012751251894515
1012751331345664
1012751433978339
1012751694961892
1012751768812632
1012751829406351

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MWI52015-02-06
BSZ32014-05-09
DWJ22023-10-24
IYN12024-09-11
GEI12022-10-05
IYO12019-06-05
DPS12012-04-25

PMN#

GUDID#