FDA.report

MEDTRONIC NAVIGATION, INC.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
17231701000517638MEDTRONIC NAVIGATION, INC.1N2026-01-01200 Medtronic Drive Lafayette CO US 80026
30047859673004785967MEDTRONIC NAVIGATION, INC. (Boxborough)1N2026-01-01200 Beaver Brook Rd Boxborough MA US 01719

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
58081146870513K992927STEALTHSTATION TREATMENT GUIDANCE PLATFORMHAW1999-12-29
58081084284832K992461STEALTHSTATION TREATMENT GUIDANCE PLATFORMHAW2000-02-22
58081008761382K992354SNT IMAGE ANALYSIS SYSTEMLLZ1999-10-12
58081781907463K991468IMMERGE IMAGE CORRELATIONLLZ1999-07-06
58081238585214K990214FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEMHAW1999-04-22
58081010833000K983670STEALTHSTATION SYSTEMHAW1999-01-14
58081055374226K983397STEALTHSTATION TREATMENT GUIDANCE PLAFFORMHAW1998-12-04
58081460714376K981768STEALTHSTATION TREATMENT GUIDANCE PLATFORMHAW1998-11-23
58081903606324K981686STEALTHSTATION SYSTEM DIGITIZER CHANGEHAW1998-08-07
58081746531904K981684STEALTHSTATION TREATMENT GUIDANCE PLATFORMHAW1998-08-06
58081868158836K974638STERITITE SEALED CONTAINERS MODEL SCO4QFRG1997-12-18
58081985956407K974187STEALTHSTATION SYSTEMHAW1998-01-21
58081472322747K974161STEALTHSTATION SYSTEMHAW1997-11-21
58081113290151K972398STEALTHSTATION PASSIVE INSTRUMENT OPTIONHAW1997-09-16
58081344514186K971247SNT DISPOSABLE BIOPSY NEEDLEHAW1997-06-16
58081136885922K963173STEALTHSTATION SYSTEMHAW1996-10-25
58081965202385K960738STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H)KCT1997-05-06
58081371524095K954276STEALTHSTATIONHAW1996-01-24
58081563605440K253395Stealth AXiS™ ENT clinical applicationPGW2026-03-16
58081807958532K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)ONO2026-03-13
58081532493533K253381Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical applicationOLO2026-02-12
58081407788843K253379Stealth AXiS Cranial clinical applicationHAW2026-03-26
58081630090136K251316Mazor X System / Mazor X Stealth EditionOLO2025-09-11
58081517188985K250307Visualase V2 MRI-guided Laser Ablation System (9736422)ONO2025-05-29
58082066330719K242464Stealth™ Spine Clamps; ModuLeX™ Shank MountsOLO2025-06-05
57871325888300K240465O-arm O2 Imaging SystemOWB2024-06-21
58081325888300K240465O-arm O2 Imaging SystemOWB2024-06-21
58082003577660K231976StealthStation Cranial Software, v3.1.5 (9735585)HAW2023-10-19
58081301174916K230064Mazor X System (Mazor X Stealth Edition)OLO2023-04-07
58081524699992K221087Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4HAW2022-06-10
58081767072168K212397StealthStation S8 Cranial v2.0HAW2021-12-22
58081340257468K211442StealthStation Spinous Process ClampsOLO2021-07-08
58081116876765K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)ONO2022-01-07
58081547030000K203639StealthStation Cranial Software v1.3.2HAW2021-01-13
58081946850983K203005Mazor XOLO2020-10-27
58081695231897K201327NavLock TrackersOLO2020-06-18
58081224216170K201189Stealthstation S8 Spine Software v1.3.0OLO2020-05-29
58081153236943K201175StealthStation Cranial Software v1.3.0HAW2020-06-03
58081475830132K200723StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)PGW2020-06-26
57871552862750K200074O-arm O2 Imaging SystemOWB2020-04-24
58081552862750K200074O-arm O2 Imaging SystemOWB2020-04-24
58081751910401K193579PlasmaBlade X 3.0S LIGHTGEI2020-03-24
58081705897178K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemHAW2019-11-01
58081888789547K190672StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1HAW2019-07-31
58081876467321K182104NavLock Trackers, Robotic Reference FrameOLO2018-11-02
58082063811376K181859Visualase Thermal Therapy SystemLLZ2019-03-06
58081973106752K181257PlasmaBlade X 3.0S, PlasmaBlade X 4.0GEI2018-08-02
58081688607020K180816Ziehm RFD 3D TrackerOLO2018-07-11
57872030603113K173664Medtronic O-arm O2 Imaging SystemOWB2017-12-29
58081173409047K171267NavLock TrackersOLO2017-07-03
58081267161922K170381Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex MiniGEI2017-09-07
58081249238321K170296CoreCath 2.7SGEI2017-03-20
58081704560862K170018StealthStationTM S8 ENT SoftwarePGW2017-05-19
58082052322922K170011StealthStation S8 Spine Software v1.0.0OLO2017-05-01
58081521526385K162655StealthConnect Remote Viewing, Planning and Collaboration SystemHAW2017-04-21
58081256818605K162604Cranial Reducing TubesHAW2016-12-30
58081134321996K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareHAW2017-03-31
58081736955899K153660StealthStation System with Cranial SoftwareHAW2016-09-14
58081742434823K153555EM ENT Navigated SuctionsPGW2016-04-07
58081970606184K153247Fusion Compact Navigation SystemPGW2016-02-18
57871386533094K151000O-Arm O2 Imaging SystemOWB2015-08-06
58081386533094K151000O-Arm O2 Imaging SystemOWB2015-08-06
58081010784335K150297PlasmaBlade UPPP and Suction CoagulatorGEI2015-05-21
58081308196121K150216Synergy CranialHAW2015-06-11
58082026793275K143628Navigated Vertex Select InstrumentsOLO2015-02-12
58082029062654K143175AEx Generator; PlasmaBlade TGEI2014-12-31
58081222089074K141833STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATIONHAW2015-03-25
58081165674755K140454NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPSOLO2014-05-22
58081259272809K133665MALLEABLE SUCTION INSTRUMENTSPGW2014-03-13
58081860456784K133444STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEMHAW2014-07-25
58081125330735K132974AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLARGEI2013-12-03
58081549257246K131425NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTEROLO2013-08-14
58081818418474K130608QUADCUTHAW2013-08-07
58081731120327K124004NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPSOLO2013-03-22
58081837210235K123201AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALERGEI2013-01-10
58082051449725K103775PEAK SUCTION COAGULATORGEI2011-05-27
58081347723578K102709PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICEGEI2010-12-17
58081481850673K102029PEAK PULSAR II GENERATOR MODEL PS100-102GEI2010-12-16
58081483824909K101057AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1GEI2011-04-05
58081922460486K093695PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICEGEI2010-04-13
57871561781587K092564O-ARM IMAGING SYSTEMOXO2010-06-17
58081561781587K092564O-ARM IMAGING SYSTEMOXO2010-06-17
58081893097467K092308POLESTAR, MODEL N-30LNH2010-03-16
58082066391697K092197PHOTEX30 DIODE LASER SERIES: 980, 810, 940GEX2009-10-06
58081678024225K083415PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICEGEI2009-06-05
58081274194944K082786PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICESGEI2008-12-03
58081478050949K082098SONOSITE MAXX SERIES ULTRASOUND SYSTEMIYN2008-08-25
58081300222154K081656VISUALASE THERMAL THERAPY SYSTEMLLZ2008-09-10
58081300222154K081656VISUALASE THERMAL THERAPY SYSTEMLLZ2008-09-10
58082064462052K081512STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGELLZ2008-07-18
58081117576435K080558STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTSFRG2008-12-05
58081434546289K073495TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHTGEI2008-01-09
58081627824825K071328VISUALASE THERMAL THERAPY SYSTEMGEX2007-08-31
58081022725736K063639AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1GEI2007-02-22
58081330237882K063505VISUALASE ENVISION SOFTWARE SYSTEMLLZ2006-12-12
58081340659141K061248AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEMHAW2006-08-31
57871503861625K060344O-ARM IMAGING SYSTEMOXO2006-03-29
58081503861625K060344O-ARM IMAGING SYSTEMOXO2006-03-29
58081676288657K060304PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940GEX2006-03-21
58082045563349K053087VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEMGEX2006-03-01
58081388898615K052859AQUAMANTYS PUMP GENERATOR SYSTEMGEI2005-10-25
58081545261695K052623IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEMHAW2006-03-02
58081592233269K051029STELTHSTATION WIRELESS SURGEON MOUSEHAW2005-06-08
57871323827508K050996O-ARM IMAGING SYSTEMOXO2005-05-05
58081323827508K050996O-ARM IMAGING SYSTEMOXO2005-05-05
58081034344664K050651MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATIONHAW2005-07-27
58081954071893K050438STEALTHSTATION SYSTEM UPDATEHAW2005-06-02
58081300005674K050237STARSHIELD V3 RF TRNTLNH2005-03-18
58081893787187K043088MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULEHAW2005-01-05
58081969431318K033621NDI PASSIVE SPHERESHAW2004-01-27
58081953384114K032541POLESTAR N-20LNH2003-09-12
58081828822270K030552IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEMHAW2003-03-19
58081928190531K030106STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULEHAW2003-02-12
58081456786477K022414STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACEHAW2002-08-14
58081557114794K022126CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEMHAW2003-01-03
58081791409163K022074SPHERZHAW2002-08-13
58081062079185K021980HIP MODULE FOR THE STEALTHSTATION SYSTEMHAW2002-11-19
58081228742564K020601FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COILMOS2002-04-24
58081739232452K020338STEALTHSTATION WITH FLUOROMERGE SOFTWAREHAW2002-02-27
58081472458709K014260TISSUELINK SOLID CYLINDER MONOPOLAR DEVICEGEI2002-03-27

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HAW492026-03-26
GEI202020-03-24
OLO162026-02-12
OWB72024-06-21
LLZ72019-03-06
PGW62026-03-16
OXO62010-06-17
GEX42009-10-06
ONO32026-03-13
LNH32010-03-16
FRG22008-12-05
IYN12008-08-25
MOS12002-04-24
KCT11997-05-06

PMA

PMN

QUADCUT

2013-08-07

MEDTRONIC NAVIGATION, INC.

Applications

GUDID

AxiEM™

2026-02-15

MEDTRONIC NAVIGATION, INC.

AxiEM™

2026-02-15

MEDTRONIC NAVIGATION, INC.

AxiEM™

2026-02-15

MEDTRONIC NAVIGATION, INC.

AxiEM™

2026-02-15

MEDTRONIC NAVIGATION, INC.

AxiEM™

2026-02-15

MEDTRONIC NAVIGATION, INC.

AxiEM™

2026-02-15

MEDTRONIC NAVIGATION, INC.

AxiEM™

2026-02-15

MEDTRONIC NAVIGATION, INC.

AxiEM™

2026-02-15

MEDTRONIC NAVIGATION, INC.

AxiEM™

2026-02-15

MEDTRONIC NAVIGATION, INC.

AxiEM™

2026-01-01

MEDTRONIC NAVIGATION, INC.

O-Arm

2025-11-27

MEDTRONIC NAVIGATION, INC.

N/A

2025-09-19

MEDTRONIC NAVIGATION, INC.

N/A

2025-09-19

MEDTRONIC NAVIGATION, INC.

N/A

2025-09-18

MEDTRONIC NAVIGATION, INC.

N/A

2025-09-18

MEDTRONIC NAVIGATION, INC.

Medtronic

2025-09-18

MEDTRONIC NAVIGATION, INC.

N/A

2025-09-18

MEDTRONIC NAVIGATION, INC.

N/A

2025-09-18

MEDTRONIC NAVIGATION, INC.