FDA.reportPublic FDA data

N/A

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96800913002806830N/A1N2027-01-01N/A N/A N/A NA US N/A
97105483003515005N/A1N2027-01-01N/A N/A N/A NA US N/A
30070847283007084728N/A1N2027-01-01N/A N/A N/A NA US N/A
30091179333009117933N/A1N2027-01-01N/A N/A N/A NA US N/A
30103378813010337881N/A1N2027-01-01N/A N/A N/A NA US N/A
30108827083010882708N/A1N2027-01-01N/A N/A N/A NA US N/A
30130363223013036322N/A1N2027-01-01N/A N/A N/A NA US N/A
30160961003016096100N/A1N2027-01-01N/A N/A N/A NA US N/A
30172336113017233611N/A1N2027-01-01N/A N/A N/A NA US N/A
30256024793025602479N/A1N2027-01-01N/A N/A N/A NA US N/A
30301250033030125003N/A1N2027-01-01N/A N/A N/A NA US N/A
30367796213036779621N/A1N2027-01-01N/A N/A N/A NA US N/A
N/A5N2026-01-01N/A N/A N/A NA US N/A
N/A5N2026-01-01N/A N/A N/A NA US N/A
N/A5N2026-01-01N/A N/A N/A NA US N/A
N/A5N2026-01-01N/A N/A N/A NA US N/A
30041051803004105180N/A1N2026-01-01N/A N/A N/A NA US N/A
30062063553006206355N/A1N2026-01-01N/A N/A N/A NA US N/A
00N/A5N2020-04-25N/A N/A N/A NA US N/A
00N/A5N2020-04-25N/A N/A N/A NA US N/A
00N/A5N2020-04-25N/A N/A N/A NA US N/A
00N/A5N2020-04-25N/A N/A N/A NA US N/A
00N/A5N2020-04-25N/A N/A N/A NA US N/A
00N/A5N2020-04-25N/A N/A N/A NA US N/A
00N/A5N2020-04-25N/A N/A N/A NA US N/A

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3103931371870757K992732STERILE WATER & STERILE 0.9% SODIUM CHLORIDEFOZ2000-04-20
898221649676110K990144INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMNAY2000-07-11
2351631649676110K990144INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMNAY2000-07-11
1641542063371269K981202WATER FILLED GUM SOOTHERKKO1998-06-16
3103931034314227K980861DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGELMGQ1998-05-20
3103931053430437K980791DUMEX PAK-ITS WOVEN RIBBON PACKINGEFQ1998-04-29
3103932004543748K960815DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLLNAD1996-04-29
3103931629307794K954743DERMAGRAN WOUND DRESSING CLEANER W/ZINCFRO1995-11-02
3103931631055324K954739DERMAGRAN HYDROPHILIC OINTMENTFRO1995-11-02
3103931869068398K954738DERMAGRAN HYDROPHILIC WOUND DRESSINGMGP1995-11-02
3103931777675187K950132DUMEX WET DRESSINGSFRO1995-03-01
3103931011865369K946326DUTEX GAUZE BANDAGEEFQ1995-01-24
3103931088806199K945830DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE)EFQ1995-01-11
3103931035388388K945802DERMAGRAN WOUND CLEANSER WITH ZINCKMF1995-02-27
3103931268712153K921291INMAN MEDICAL PACKING STRIPFER1993-01-21
3103931201323081K921290INMAN MEDICAL OIL EMULSION DRESSINGFRO1992-11-23
3103931384871027K921289INMAN MEDICAL PETROLATUM DRESSINGFRO1992-11-10
3103931960820326K914746DERMAGRAN WET DRESSINGMGQ1992-06-17
828141328072383K902591CYTETTE(TM) CYTOLOGY BRUSHHHT1990-09-10
828142004956266K902589CYTOSET(TM)HHT1990-09-10
3103931358732969K894205TECNOL SILK STRIPFPX1989-07-25
2351631743071293K261249Universal Seal (5-12 mm)GCJ2026-07-14
2351631599223762K253986da Vinci Force Feedback InstrumentsNAY2026-03-11
2351631365162556K253978Universal Seal (5-12 mm)GCJ2026-02-24
2351631667031296K250674Vessel Sealer Curved (480522)NAY2025-06-13
2351631734258843K243641da Vinci Surgical System (IS5000)NAY2024-12-16
2351631277276069K243582da Vinci SP Advanced Access Port Kit (432701)NAY2025-02-28
2351631936952756K241814da Vinci SP Instruments (SP1098)NAY2024-11-18
2351631770965988K2416388mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 ReloadsNAY2024-09-10
198491328302233K240648Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)FLL2024-06-05
2351631795948760K240135Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)EOQ2024-04-03
898221795948760K240135Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)EOQ2024-04-03
3235702028209581K230842SignalHF (IM008)QNL2023-10-25
898221288643416K222839EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 SystemNAY2023-03-16
2351631288643416K222839EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 SystemNAY2023-03-16
2351631585445372K2200238mm Monopolar Curved ScissorsNAY2022-01-31
2351631354427278K214095da Vinci X/Xi (IS4200/IS4000) 8mm Reusable InstrumentsNAY2022-08-15
898221291694215K212048Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)EOQ2021-08-26
2351631291694215K212048Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)EOQ2021-08-26
1230931805390074K211279Volpara Imaging SoftwareLLZ2021-07-27
3235701261911261K210543IM007DQK2021-11-03
2351631891963264K202571da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesNAY2020-11-12
2750321487662493K201713AVVIGO Guidance SystemDQK2020-07-23
2351631807204684K191736da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30NAY2019-07-26
2351631682044864K191280E-100 Electrosurgical Generator, SynchroSealNAY2019-11-14
898221318573614K190999SureForm 45 Curved Tip, SureForm 45 Gray ReloadNAY2019-07-12
2351631318573614K190999SureForm 45 Curved Tip, SureForm 45 Gray ReloadNAY2019-07-12
898221412807843K183224SureForm 45, SureForm 45 ReloadsNAY2019-01-18
2351631412807843K183224SureForm 45, SureForm 45 ReloadsNAY2019-01-18
2351631701227604K183107Intuitive Surgical Vessel Sealer ExtendNAY2018-12-11
2351631023001908K182371da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY2019-03-14
2351631353974353K182188Ion Endoluminal System ; Flexision Biopsy NeedleEOQ2019-02-14
2351631509308041K180351EndoWrist Mercury Bipolar GrasperNAY2018-08-07
898222001832704K1800338mm Monopolar Curved ScissorsNAY2018-04-06
2351632001832704K1800338mm Monopolar Curved ScissorsNAY2018-04-06
2351631851755254K173906da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY2018-05-31
898221667067088K173721SureForm 60 and SureForm 60 ReloadsNAY2018-07-05
2351631667067088K173721SureForm 60 and SureForm 60 ReloadsNAY2018-07-05
898221306520926K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendNAY2018-04-26
2351631306520926K173337Intuitive Surgical EndoWrist Vessel Sealer ExtendNAY2018-04-26
898221112190839K162973EndoWrist Suction IrrigatorNAY2017-02-06
2351631112190839K162973EndoWrist Suction IrrigatorNAY2017-02-06
2351631148924273K162411da Vinci Xi 12 – 8 mm ReducerNAY2016-09-21
898221148924273K162411da Vinci Xi 12 – 8 mm ReducerNAY2016-09-21
198491176032459K162083RII Multi-function Infrared Thermometer, Model TH52ZFLL2017-01-09
1230931749744100K153427Volpara Imaging SoftwareLLZ2016-01-07
898221045176031K153126da Vinci Xi Hasson ConeGCJ2015-12-09
2351631045176031K153126da Vinci Xi Hasson ConeGCJ2015-12-09
898221131717527K152663Bladeless Optical ObturatorsGCJ2015-10-16
2351631131717527K152663Bladeless Optical ObturatorsGCJ2015-10-16
898221566601086K152448da Vinci Single-Site Instrument and AccessoriesNAY2016-03-09
2351631566601086K152448da Vinci Single-Site Instrument and AccessoriesNAY2016-03-09
898221672985548K152421IS4000 Stapler 30 Instrument and Stapler 30 ReloadsNAY2016-03-04
2351631672985548K152421IS4000 Stapler 30 Instrument and Stapler 30 ReloadsNAY2016-03-04
1230931577394063K152028Volpara Imaging SoftwareLLZ2015-10-26
2351631022836725K150837IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsNAY2015-04-29
2351631941799083K150284IS4000 da Vinci EndoWrist InstrumentsNAY2015-05-15
898221655171763K143132IS4000 8mm Harmonic ACE Curved ShearsNAY2015-04-02
2351631655171763K143132IS4000 8mm Harmonic ACE Curved ShearsNAY2015-04-02
898221797047205K140553ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADSNAY2014-07-25
2351631797047205K140553ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADSNAY2014-07-25
898221938095292K140189ENDOWRIST VESSEL SEALERNAY2014-06-05
2351631938095292K140189ENDOWRIST VESSEL SEALERNAY2014-06-05
898222066551524K1338458MM TROCAR KITGCJ2014-02-19
2351632066551524K1338458MM TROCAR KITGCJ2014-02-19
898222016260083K133203SINGLE-SITE PORTGCJ2014-05-09
2351632016260083K133203SINGLE-SITE PORTGCJ2014-05-09
1641541519537622K132220PJ'S SERENITYHGX2015-02-20
898221443792233K131861DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESNAY2014-03-28
2351631443792233K131861DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIESNAY2014-03-28
898221791132569K130726DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOKNAY2013-06-07
2351631791132569K130726DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOKNAY2013-06-07
898221984046067K122532DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIESNAY2013-07-30
2351631984046067K122532DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIESNAY2013-07-30
198491209831497K121428NON-CONTACT CLINICAL THERMOMETERFLL2012-07-17
898221252929030K113706ENDOWRIST STAPLER SYSTEMNAY2012-10-17
2351631252929030K113706ENDOWRIST STAPLER SYSTEMNAY2012-10-17
2351631601899810K1125845MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERTNAY2011-09-29
898221397979857K112263MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORYNAY2011-10-07
2351631397979857K112263MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORYNAY2011-10-07
898221707849165K112208INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIESNAY2011-12-08
2351631707849165K112208INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIESNAY2011-12-08
198491502450224K111637INFRARED EAR THERMOMETERFLL2011-12-06
898221643151995K110639ENDOWRIST ONE VESSEL SEALERNAY2011-12-28
2351631643151995K110639ENDOWRIST ONE VESSEL SEALERNAY2011-12-28
898221114366981K110451ENDOWRIST ONE SUCTION/IRRIGATORNAY2011-08-26
2351631114366981K110451ENDOWRIST ONE SUCTION/IRRIGATORNAY2011-08-26
198491274325370K103097INFRARED EAR THERMOMETERFLL2010-12-29
1230931622578874K102556VOLPARA, VERSION 1.3LLZ2010-10-07
198491066860990K102187RII INFRARED EAR THERMOMETER,FLL2010-12-10
198491244246603K101253RII INFRARED EAR THERMOMETER, MODEL: TH60NFLL2010-06-29
898222014737647K101077DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100GCJ2011-02-04
2351632014737647K101077DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100GCJ2011-02-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NAY812026-03-11
GCJ152026-07-14
FLL142024-06-05
FRO62008-06-27
EOQ52024-04-03
LLZ52021-07-27
EFQ31998-04-29
DQK22021-11-03
HGX22015-02-20
KKO22009-12-07
GEI22002-01-10
MGQ21998-05-20
HHT21990-09-10
QNL12023-10-25
FOZ12000-04-20
NAD11996-04-29
MGP11995-11-02
KMF11995-02-27
FER11993-01-21
FPX11989-07-25