FDA.reportPublic FDA data

Medivators Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16513953003012447Medivators Inc1Y2026-01-013150 Pollok Drive Conroe TX US 77303
21500602150060Medivators Inc1Y2026-01-0114605 28th Avenue North MINNEAPOLIS MN US 55447
30188111673018811167MEDIVATORS INC1N2026-01-0114585 Northdale Blvd Rogers MN US 55374

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
59711712941486K993042MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANTMED2000-08-17
59711679916174K992893DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGEEIA1999-09-08
59711995239893K992868DENTAPURE DP40 CARTRIDGEEIA1999-09-07
59711072256783K991851RENACLEAR DIALYZER CLEANING SYSTEMLIF1999-08-30
59711966562656K983126FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERSFIP1999-03-08
59711450954457K983085HEMOCOR HPH 700 HEMOCONCENTRATORKDI1998-11-13
59711289485783K980859HEMOCOR HPH MINI HEMOCONCENTRATORKDI1998-05-12
59711169494502K970648PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)MSF1998-01-05
59711789852882K964264HIGH RANGE PEROXIDE TEST STRIPFKP1997-06-16
59711803852553K962707MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SETKDI1996-10-09
59711882380478K954349FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERSFIP1995-12-15
59711952121253K931935ENDPOINT 500 PERACETIC ACID TEST INDICATORSJOJ1994-02-07
59711803869145K923727PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000KDI1994-07-29
59711824042905K923312HIGH PERMEABILITY DIALYERKDI1994-02-18
59711497841373K923139HEMOCOR HP HEMOCONCENTRATOR SERIESKDI1994-02-18
59711283377490K914145DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPESFEB1994-02-22
59711181668870K913483MINNILERT(R) PRESSURE MONITORKOC1991-09-27
59711278138718K904992MINNILERT AIR DETECTORFJF1991-02-05
59711881068787K904210RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330LIF1990-11-27
59711804771979K871712MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.NVE1988-01-14
59711268044499K861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTFKQ1987-06-09
59711383794914K843963DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWDFKQ1985-01-07
59711780022280K841543CONCENTRATE CONDUCTIVITY METERFKQ1984-05-22
59711252224396K840182RENAPAK CONCENTRATE MIXING SYS.FKQ1984-05-02
59711877735691K834596BLOOD TUBINGKOC1984-02-04
59711342235079K832458AUTOMATIC ENDOSCOPENVE1983-10-20
59711374791956K830575RENALIN (TENTATIVELIF1983-03-31
59711038839561K771705RS-7800 MINIPUMPFIR1977-10-04
59711465255293K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118JOJ2025-05-02
1342071871090722K243075Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)ODC2024-11-08
1342071891557075K240352Defendo Single Use Cleaning Adapter for Olympus EndoscopesODC2024-03-06
1342071518202648K232329Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning AdapterODC2023-12-21
1342071412632739K232067Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use ConnectorODC2024-03-22
1342071469731890K232004Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use ConnectorODC2024-03-06
1342071958916218K231418ENDOGATOR™ Hybrid Irrigation TubingOCX2023-08-14
1342071719866251K230280ANDORATE® Suction Valve and ANDORATE® Biopsy ValveKTI2023-05-11
1342071242918829K223040Endo SmartCapFAJ2023-03-01
1342071978263734K220395EndoGator Endoscopy Irrigation TubingFEQ2022-03-11
59711889792110K213833SCOPE BUDDY PLUS Endoscope Flushing AidFEB2022-01-14
1342071889792110K213833SCOPE BUDDY PLUS Endoscope Flushing AidFEB2022-01-14
59711419966130K172677Advantage Plus Pass-ThruFEB2017-12-19
59711184661264K162128Scope Buddy Plus Endoscope Flushing AidFEB2016-12-21
1342071184661264K162128Scope Buddy Plus Endoscope Flushing AidFEB2016-12-21
1342071901376735K160846AmplifEYEFED2016-07-14
59711804537432K152394Rapicide PA High-Level Disinfectant Test StripsJOJ2016-03-11
59711389070513K133724MINNCARE HDNIH2014-08-27
1342072064847141K123428MIROCAM CAPSULE ENDOSCOPE SYSTEMNEZ2013-05-20
59712064847141K123428MIROCAM CAPSULE ENDOSCOPE SYSTEMNEZ2013-05-20
1342071283007267K122565ARC ENDOCUFFFED2012-09-04
59711947534565K120702E.G. SCAN II ESPHAGOSCOPE SYSTEMEOX2012-06-20
59711468348203K120652RAPICIDE OPA-28 TEST STRIPJOJ2012-10-12
59711112162382K120306RAPICIDE OPA-28MED2012-09-27
1342071976189760K113806KIMGUARD ONE STEP STERILIZATION WRAPFRG2013-08-20
59711978197150K113310ENDOGATER AVANTAGE CO2 INSUFFLATORFCX2012-06-20
1342071978197150K113310ENDOGATER AVANTAGE CO2 INSUFFLATORFCX2012-06-20
59711710086028K113119ENDOGATOR ADVANTAGE IRRIGATION PUMPOCX2012-04-27
1342071710086028K113119ENDOGATOR ADVANTAGE IRRIGATION PUMPOCX2012-04-27
1342071335047910K110088DEFENDO Y-OPSY IRRIGATORODC2011-06-10
59711048095243K102996MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSORFEB2011-01-13
1342071625910096K102855UNIVERSAL IRRIGATION SOLUTION HYBRIDOCX2010-11-19
1342071971563717K102581DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305ODC2010-11-08
1342072006559331K102409DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304ODC2010-11-04
1342071411521492K093718ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003FCY2010-02-22
1342071771233392K093665ENDO SMARTCAPFAJ2009-12-15
59711910162854K092429ENDOGATORFEQ2009-11-19
1342071910162854K092429ENDOGATORFEQ2009-11-19
59711800199847K092387MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEMFEB2010-04-05
1342072003527099K090851DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)ODC2009-07-02
59711134186724K082988MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM, RAPICIDE PA HIGH LEVEL DISINFECTANTFEB2009-02-13
59711399703262K080750BROWNE RAPICIDE GLUTARALDEHYDE INDICATORJOJ2008-05-12
59711249854629K072601OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANTGXP2007-12-10
1342071363243906K071459B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGESFMF2007-08-16
59711310525865K071298HF JUNIOR HEMOFILTERKDI2007-08-08
1342071254011284K070432GENERAL SURGERY DRAPESKKX2007-09-24
59711747277640K063876MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSINGFEB2007-06-14
1342071583360175K063813VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULACCK2008-03-26
1342071147871286K062969MEDLINE STERILE DISPOSABLE SURGICAL GOWNSFYA2006-12-14
59711504984307K060962ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100OCX2006-04-19
1342071504984307K060962ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100OCX2006-04-19
59711526785518K050952HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATORKDI2006-01-31
1342071382871095K041060E-Z LUBRICATING JELLYKMJ2004-05-07
1342071649078528K033695IRRIGATION CHANNEL TUBING, MODEL 100135OCX2003-12-23
59711618302296K033505RENACLEAN SH DIALYZER CLEANING SYSTEMLIF2004-04-27
1342071635609598K020593CONVERTORS SMS POLYOLEFIN GOWNFYA2002-03-18
59711552479246K000028RENAFLO II HF 2000 HEMOFILTERKDI2000-04-04
1342071012807682
59711227742636
59711229020377
1342071286406713
1342071290417268
1342071309667223
59711338373807
1342071446181271
1342071504836623
1342071623000823
1342071844790224
1342071868956019
59711868956019
1342071917313918
59711917313918
59711936689947
1342071973658597
1342072067475366
59712067475366
1342071066783009
1342071137091903
59711261310762
59711270243772
59711311317361
1342071338373807
3445341342519207
1342071409253687
59711409253687
59711410444865
1342071429254526
59711583154352
1342071655361218
1342071668956881

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FEB102022-01-14
ODC92024-11-08
KDI92007-08-08
OCX72023-08-14
JOJ62025-05-02
LIF42004-04-27
FKQ41987-06-09
FEQ32022-03-11
FAJ22023-03-01
FED22016-07-14
NEZ22013-05-20
MED22012-09-27
FCX22012-06-20
FYA22006-12-14
EIA21999-09-08
FIP21999-03-08
KOC21991-09-27
NVE21988-01-14
KTI12023-05-11
NIH12014-08-27
FRG12013-08-20
EOX12012-06-20
FCY12010-02-22
CCK12008-03-26
GXP12007-12-10
KKX12007-09-24
FMF12007-08-16
KMJ12004-05-07
MSF11998-01-05
FKP11997-06-16
FJF11991-02-05
FIR11977-10-04

PMN#