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Medtronic Navigation, Inc.

35 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Stealth AXiS Cranial clinical application (K253379)Medtronic Navigation, Inc.2026-03-26
Stealth AXiS™ ENT clinical application (K253395)Medtronic Navigation, Inc.2026-03-16
Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) (K253391)Medtronic Navigation, Inc.2026-03-13
Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application (K253381)Medtronic Navigation, Inc.2026-02-12
StealthStation S8 Spine Software (K251282)Medtronic Navigation, Inc.2025-10-17
Stealth™ Spine Clamps; ModuLeX™ Shank Mounts (K242464)Medtronic Navigation, Inc.2025-06-05
O-arm O2 Imaging System (K240465)Medtronic Navigation, Inc.2024-06-21
StealthStation Cranial Software, v3.1.5 (9735585) (K231976)Medtronic Navigation, Inc.2023-10-19
Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 (K221087)Medtronic Navigation, Inc.2022-06-10
Visualase MRI-Guided Laser Ablation System (SW 3.4) (K211269)Medtronic Navigation, Inc.2022-01-07
StealthStation Cranial Software v1.3.2 (K203639)Medtronic Navigation, Inc.2021-01-13
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) (K200723)Medtronic Navigation, Inc.2020-06-26
StealthStation Cranial Software v1.3.0 (K201175)Medtronic Navigation, Inc.2020-06-03
Stealthstation S8 Spine Software v1.3.0 (K201189)Medtronic Navigation, Inc.2020-05-29
Stealth Autoguide System, Midas Rex Legend Depth Stop System (K191597)Medtronic Navigation, Inc.2019-11-01
StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 (K190672)Medtronic Navigation, Inc.2019-07-31
Visualase Thermal Therapy System (K181859)Medtronic Navigation, Inc.2019-03-06
StealthStationTM S8 ENT Software (K170018)Medtronic Navigation, Inc.2017-05-19
StealthConnect Remote Viewing, Planning and Collaboration System (K162655)Medtronic Navigation, Inc.2017-04-21
StealthStation S8 System Platforms and StealthStation Cranial Software (K162309)Medtronic Navigation, Inc.2017-03-31
Cranial Reducing Tubes (K162604)Medtronic Navigation, Inc.2016-12-30
StealthStation System with Cranial Software (K153660)Medtronic Navigation, Inc.2016-09-14
EM ENT Navigated Suctions (K153555)Medtronic Navigation, Inc.2016-04-07
Fusion Compact Navigation System (K153247)Medtronic Navigation, Inc.2016-02-18
Synergy Cranial (K150216)Medtronic Navigation, Inc.2015-06-11
STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION (K141833)Medtronic Navigation, Inc.2015-03-25
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM (K133444)Medtronic Navigation, Inc.2014-07-25
MALLEABLE SUCTION INSTRUMENTS (K133665)Medtronic Navigation, Inc.2014-03-13
NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER (K131425)Medtronic Navigation, Inc.2013-08-14
QUADCUT (K130608)Medtronic Navigation, Inc.2013-08-07
NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS (K124004)Medtronic Navigation, Inc.2013-03-22
STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE (K081512)Medtronic Navigation, Inc.2008-07-18
AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM (K061248)Medtronic Navigation, Inc.2006-08-31
IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM (K052623)Medtronic Navigation, Inc.2006-03-02
MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION (K050651)Medtronic Navigation, Inc.2005-07-27

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Every clearance here is in the API, with alerts when new ones post.