FDA.reportPublic FDA data

Biomerics ATL, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18331171833117Biomerics ATL, LLC1N2020-04-256102 Victory Way INDIANAPOLIS IN US 46278

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
335261801027862K990387ENDOMETRIAL SAMPLERHHK1999-04-20
335261813451824K974357UTERINE MANIPULATOR/INJECTORLKF1998-02-02
335261393251428K946044DISPOSABLE GAS SAMPLING LINESCCK1994-12-27
335261247888365K914337GAS SAMPLING INTERFACESCCK1992-03-11
335261045375749K882329L-F COILED EXTENSION TUBINGDXT1988-09-02
335261033859720K172299Accordion Piccolo Stone Management DeviceFFL2017-09-19
335261194033413K162075NICO TRIOwandGEI2016-08-11
335261369458474K160942SonablatePLP2016-12-21
335261339733183K141666FERTILIGENT SLOW RELEASE IUI CATHETER KITMQF2015-02-03
335261835662937K130736BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESISLRC2013-12-17
335261224632670K123258THE ADVANCE CATHETER FOR HSG AND SISLKF2013-01-31
335261319846260K120154INTRAUTERINE INSEMINATION (IUI) CATHETERMQF2012-03-21
335261270607638K102887ACCORDION STONE MANAGEMENT DEVICE MODEL AC281205 AND AC3814510FFL2011-05-16
335261182093056K090785MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214MWI2009-12-15
335261160543474K082803COAXIAL ACCORDION STONE MANAGEMENT DEVICE, MODEL: COAC12005 - COA20015FFL2008-11-13
335261886527731K042744OPTIV ANTAGE DH POWER INJECTION SYSTEMDXT2004-11-30
335261985849556K042290VACUUM ASSISTED CORE BIOPSY DEVICEKNW2004-10-06
335261704846334K032835H/S CATHETER SETLKF2003-12-11
335261116283627K022593THOMAS MEDICAL ELECTRODESHGI2002-11-01
335261138819041K020292UTERINE INJECTORLKF2002-04-17
335261638372636DEN150011Sonablate 450PLP2015-10-09
335261213245071
335261649068606
335261708106819
335261776641138
335261898188128
335261919464248
335261924960400

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LKF42013-01-31
FFL32017-09-19
PLP22016-12-21
MQF22015-02-03
DXT22004-11-30
CCK21994-12-27
GEI12016-08-11
LRC12013-12-17
MWI12009-12-15
KNW12004-10-06
HGI12002-11-01
HHK11999-04-20