Medtronic Navigation Inc

FDA Filings

This page includes the latest FDA filings for Medtronic Navigation Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Medtronic Navigation Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1723170
FEI Number1000517638
NameMEDTRONIC NAVIGATION, INC.
Owner & OperatorMEDTRONIC INC.
Contact Address710 Medtronic Pkwy.
Minneapolis MN 55432 US
Official Correspondent
  • CHRISTINE - BOES
  • x-763-5260396-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address826 COAL CREEK CIR.
LOUISVILLE, CO 80027 US
Establishment Type
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
MEDTRONIC NAVIGATION, INC.
Visualase 2020-07-06
MEDTRONIC NAVIGATION, INC.
StealthStation 2020-07-06
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ X 2020-07-03
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ X 2020-07-03
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ X 2020-07-03
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ X 2020-07-03
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ X 2020-07-03
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ X 2020-07-03
MEDTRONIC NAVIGATION, INC.
NavLock 2020-06-29
MEDTRONIC NAVIGATION, INC.
NavLock 2020-06-29
MEDTRONIC NAVIGATION, INC.
NavLock 2020-06-29
MEDTRONIC NAVIGATION, INC.
NavLock 2020-06-29
Medtronic Navigation Inc.
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)2020-06-26
Medtronic Navigation Inc.
StealthStation Cranial Software V1.3.02020-06-03
Medtronic Navigation, Inc.
Stealthstation S8 Spine Software V1.3.02020-05-29
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ 2020-05-26
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ 2020-05-26
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ 2020-05-26
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ 2020-05-26
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ 2020-05-26
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ 2020-05-26
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ 2020-05-26
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ 2020-05-26
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ 2020-05-26
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ 2020-05-26
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ 2020-05-26
MEDTRONIC NAVIGATION, INC.
Visualase 2020-05-25
MEDTRONIC NAVIGATION, INC.
N/A 2020-05-18
MEDTRONIC NAVIGATION, INC.
N/A 2020-05-18
MEDTRONIC NAVIGATION, INC.
N/A 2020-05-18
MEDTRONIC NAVIGATION, INC.
N/A 2020-05-18
MEDTRONIC NAVIGATION, INC.
N/A 2020-05-18
MEDTRONIC NAVIGATION, INC.
N/A 2020-05-18
MEDTRONIC NAVIGATION, INC.
N/A 2020-05-18
MEDTRONIC NAVIGATION, INC.
N/A 2020-05-18
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ X 2020-05-18
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ X 2020-05-18
MEDTRONIC NAVIGATION, INC.
PlasmaBlade™ X 2020-05-18
MEDTRONIC NAVIGATION, INC.
SureTrak® 2020-05-18
MEDTRONIC NAVIGATION, INC.
N/A 2020-05-11
MEDTRONIC NAVIGATION, INC.
N/A 2020-05-04
MEDTRONIC NAVIGATION, INC.
N/A 2020-05-04
MEDTRONIC NAVIGATION, INC.
Visualase 2020-05-04
MEDTRONIC NAVIGATION, INC.
N/A 2020-05-01
MEDTRONIC NAVIGATION, INC.
N/A 2020-04-17
MEDTRONIC NAVIGATION, INC.
Aquamantys™ 2020-04-06
MEDTRONIC NAVIGATION, INC.
Aquamantys™ 2020-04-06
MEDTRONIC NAVIGATION, INC.
Aquamantys™ 2020-04-06
MEDTRONIC NAVIGATION, INC.
Aquamantys™ 2020-04-06
MEDTRONIC NAVIGATION, INC.
Aquamantys™ 2020-04-06
MEDTRONIC NAVIGATION, INC.
Aquamantys™ 2020-04-06
MEDTRONIC NAVIGATION, INC.
Aquamantys™ 2020-04-06
MEDTRONIC NAVIGATION, INC.
Aquamantys™ 2020-04-06
MEDTRONIC NAVIGATION, INC.
Aquamantys™ 2020-04-06
MEDTRONIC NAVIGATION, INC.
Aquamantys™ 2020-04-06
MEDTRONIC NAVIGATION, INC.
2020-04-06
MEDTRONIC NAVIGATION, INC.
Aquamantys™ 2020-04-06
MEDTRONIC NAVIGATION, INC.
Aquamantys™ 2020-04-06
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
PlasmaBlade X 3.0S LIGHT2020-03-30
MEDTRONIC NAVIGATION, INC.
RadiaLux™ 2020-03-23
MEDTRONIC NAVIGATION, INC.
RadiaLux™ 2020-03-23
MEDTRONIC NAVIGATION, INC.
N/A 2020-03-23
MEDTRONIC NAVIGATION, INC.
StealthStation™ 2020-03-09
MEDTRONIC NAVIGATION, INC.
StealthStation 2020-03-02
MEDTRONIC NAVIGATION, INC.
N/A 2020-03-02
MEDTRONIC NAVIGATION, INC.
Synergy 2020-02-24
MEDTRONIC NAVIGATION, INC.
N/A 2020-02-17
MEDTRONIC NAVIGATION, INC.
Vertek® 2020-02-17
MEDTRONIC NAVIGATION, INC.
Vertek® 2020-02-17
MEDTRONIC NAVIGATION, INC.
AxiEM™ Spine Reference Clamp 2020-02-17
MEDTRONIC NAVIGATION, INC.
Synergy® 2020-02-03
MEDTRONIC NAVIGATION, INC.
Synergy® 2020-02-03
MEDTRONIC NAVIGATION, INC.
Synergy® 2020-02-03
MEDTRONIC NAVIGATION, INC.
Synergy® 2020-02-03
MEDTRONIC NAVIGATION, INC.
N/A 2020-01-31
MEDTRONIC NAVIGATION, INC.
N/A 2020-01-31
MEDTRONIC NAVIGATION, INC.
N/A 2020-01-31
MEDTRONIC NAVIGATION, INC.
N/A 2020-01-31
MEDTRONIC NAVIGATION, INC.
N/A 2020-01-31
MEDTRONIC NAVIGATION, INC.
N/A 2020-01-31
MEDTRONIC NAVIGATION, INC.
N/A 2020-01-31
MEDTRONIC NAVIGATION, INC.
N/A 2020-01-31
MEDTRONIC NAVIGATION, INC.
N/A 2020-01-31
MEDTRONIC NAVIGATION, INC.
N/A 2020-01-31
MEDTRONIC NAVIGATION, INC.
N/A 2020-01-31
MEDTRONIC NAVIGATION, INC.
N/A 2020-01-31
MEDTRONIC NAVIGATION, INC.
N/A 2020-01-31
MEDTRONIC NAVIGATION, INC.
N/A 2020-01-31
MEDTRONIC NAVIGATION, INC.
N/A 2020-01-27
MEDTRONIC NAVIGATION, INC.
O-ARM® 2020-01-17
MEDTRONIC NAVIGATION, INC.
Stealth Autoguide™ System 2020-01-06
MEDTRONIC NAVIGATION, INC.
Stealth Autoguide™ System 2020-01-06
MEDTRONIC NAVIGATION, INC.
Stealth Autoguide™ System 2020-01-06
MEDTRONIC NAVIGATION, INC.
Stealth Autoguide™ System 2020-01-06
MEDTRONIC NAVIGATION, INC.
Stealth Autoguide™ System 2020-01-06
MEDTRONIC NAVIGATION, INC.
Stealth Autoguide™ System 2020-01-06
MEDTRONIC NAVIGATION, INC.
Stealth Autoguide™ System 2020-01-06
MEDTRONIC NAVIGATION, INC.
Stealth Autoguide™ System 2020-01-06
MEDTRONIC NAVIGATION, INC.
Stealth Autoguide™ System 2020-01-06
MEDTRONIC NAVIGATION, INC.
Stealth Autoguide™ System 2020-01-06
MEDTRONIC NAVIGATION, INC.
Stealth Autoguide™ System 2020-01-06
MEDTRONIC NAVIGATION, INC.
Stealth Autoguide™ System 2020-01-06
MEDTRONIC NAVIGATION, INC.
Stealth Autoguide™ System 2020-01-06
MEDTRONIC NAVIGATION, INC.
Stealth Autoguide™ System 2020-01-06
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Stealth Autoguide2019-12-05
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Midas Rex Legend Depth Stop System2019-12-05
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Stealth Autoguide2019-12-05
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Midas Rex Legend Depth Stop System2019-12-05
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Stealth Autoguide2019-12-05
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Midas Rex Legend Depth Stop System2019-12-05
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Stealth Autoguide2019-12-05
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Midas Rex Legend Depth Stop System2019-12-05
Medtronic Navigation, Inc.
Stealth Autoguide System, Midas Rex Legend Depth Stop System2019-11-01
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation Synergy Cranial S7 Software v.2.2.8,2019-08-12
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation Cranial Software v3.1.12019-08-12
Medtronic Navigation Inc
StealthStation Synergy Cranial S7 Software V.2.2.8, StealthStation Cranial Software V3.1.12019-07-31
Medtronic Navigation Inc.
Visualase Thermal Therapy System2019-03-06
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
NavLock Trackers2019-01-24
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
NavLock Trackers and Robotic Reference Frame2018-11-30
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation System2018-11-12
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation System2018-11-12
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Ziehm2018-07-25
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthConnect Remote Viewing, Planning and Collaboration System2018-03-07
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthConnect Remote Viewing, Planning and Collaboration System2018-03-07
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation S8 ENT Software2017-05-23
Medtronic Navigation, Inc.
StealthStationTM S8 ENT Software2017-05-19
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation S8 Spine Software2017-05-08
MEDTRONIC NAVIGATION, INC.
StealthConnect Remote Viewing, Planning And Collaboration System2017-04-21
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Stealthstation S8 System Platforms and StealthStation Cranial Software2017-04-02
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Stealthstation S8 System Platforms and StealthStation Cranial Software2017-04-02
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Stealthstation S8 System Platforms and StealthStation Cranial Software2017-04-02
MEDTRONIC NAVIGATION, INC.
StealthStation S8 System Platforms And StealthStation Cranial Software2017-03-31
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Tube Set 9735998 Cranial Reducing2017-01-25
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Reducing Tube 9735734 4.0mm Cranial2017-01-25
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Reducing Tube 9735733 3.2mm Cranial2017-01-25
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Reducing Tube 9735732 1.7mm Cranial2017-01-25
MEDTRONIC NAVIGATION, INC.
Cranial Reducing Tubes2016-12-30
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation System with StealthStation Cranial Software2016-09-21
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Visualase (9735564)2016-09-21
MEDTRONIC NAVIGATION, INC.
StealthStation System With Cranial Software2016-09-14
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Aquamantys SBS 5.0 Sheathed Bipolar Sealer (23-312-1)2016-05-23
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Aquamantys Mini EVS 3.4 Epidural Vein Sealer (23-314-1)2016-05-23
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Aquamantys Epidural Vein Sealer (23-121-1)2016-05-23
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Aquamantys 2.3 Bipolar Sealer (23-113-1);2016-05-23
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
EM ENT Navigated Suction2016-04-28
MEDTRONIC NAVIGATION, INC.
EM ENT Navigated Suctions2016-04-07
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
FUSION Compact Navigation System2016-03-04
MEDTRONIC NAVIGATION, INC.
Fusion Compact Navigation System2016-02-18
MEDTRONIC NAVIGATION, INC.
Synergy Cranial2015-06-11
MEDTRONIC NAVIGATION, INC.
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION2015-03-25
MEDTRONIC NAVIGATION, INC.
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM2014-07-25
MEDTRONIC NAVIGATION, INC.
MALLEABLE SUCTION INSTRUMENTS2014-03-13
MEDTRONIC NAVIGATION, INC.
NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER2013-08-14
MEDTRONIC NAVIGATION, INC.
QUADCUT2013-08-07
MEDTRONIC NAVIGATION, INC.
NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS2013-03-22
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
PEAK PlasmaBlade 3.0S (Model Number: PS210-030S, PS210-030S-SP, PS210-030SE)2012-11-28
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
PEAK PlasmaBlade Tonsil (PS300-001, PS300-001E, PS300-003, SP300-003E)2012-11-28
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
PEAK PlasmaBlade Needle (Model Number: PS200-001, PS200-001-SP, PS200-001E, PS200-001SPE)2012-11-28
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Ultrasound2012-11-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Ultrasound2012-11-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Ultrasound2012-11-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Ultrasound2012-11-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Tunneling Tool Accessory Kit2012-02-28
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Pocket sizer2012-02-28
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
DBS Tunneling tool2012-02-28
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Stealth Station Sterilization Change2011-01-31
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation Natrex2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation Treatment Guidance Platform2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Image Analysis System2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Immerge Image Correlation V22011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation Fluoro Nav Module2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation System-Digitizer2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation -Battery Marker Option2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation ENT Application2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation (Drill attachment)2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation- Sterrad2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Stealth Viz Software2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation AxiEM Imageless Hip2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation Orthopaedic Trauma2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation AxiEM Imageless Knee Module2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation Imageless Knee Module2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation Advanced Contour Registration2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation 3D for C-Arm2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation Hip Module2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation Software2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation Knee Module2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation Treatment Guidance Platform2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation Laser Registration Device2011-01-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation Universal Attachment2010-08-18
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Steritite Sealed Containers2009-12-30
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
StealthStation Wireless Mouse2009-12-30
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
GoldenEye Micro-Magnetic Tracking2009-12-30
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Neurological Sterotaxic Instrument2009-05-19
MEDTRONIC NAVIGATION, INC.
STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE2008-07-18
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Flexicoil2007-12-12
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Polestar N-202007-12-10
MEDTRONIC NAVIGATION, INC.
AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM2006-08-31
MEDTRONIC NAVIGATION, INC.
IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM2006-03-02
MEDTRONIC NAVIGATION, INC.
MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION2005-07-27
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Retractor2005-03-23
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
XOMED1995-04-14
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Visualase1995-04-14
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
MULTIPLE Manual Surgical Instruments1995-04-14
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
MICRO-FRANCE Manual Surgical Instr1995-04-14
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
KyphX Handle; Introducer1995-04-14
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Visualase1994-11-09
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Slap Hammer1994-11-09
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Manual surgical instrument for general use1994-11-09
MEDTRONIC NAVIGATION, INC. [MEDTRONIC INC.]
Visualase (9735563)1992-12-21

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