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Panels › Neurology › Product code HAW · Class 2

Neurological Stereotaxic Instrument

Regulation 882.4560

5510(k)s in 12 months (426 all time)
7recalls in 12 months (202 all time)
199recalls that name a 510(k)
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Top companies in HAW

Company510(k)sRecalls
Medtronic Navigation1967
Brainlab599
FHC, Inc.624
Elekta Instrument AB164
Stryker Instruments Division of Stryker Corporation019
Stryker Instruments Div. of Stryker Corporation017
Zimmer Biomet, Inc.016
Image-Guided Neurologics, Inc.150
Surgical Navigation Technologies, Inc.150
Medtronic Surgical Navigation Technologies111
Decided510(k)Device and applicantCode
Jan 13, 2021K203639StealthStation Cranial Software v1.3.2
Medtronic Navigation, Inc.
HAW
Oct 8, 2020K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial
Brainlab AG, DE
HAW
Jun 3, 2020K201175StealthStation Cranial Software v1.3.0
Medtronic Navigation, Inc.
HAW
May 29, 2020K200511ROSA ONE Brain application
Medtech S.A, FR
HAW
Apr 6, 2020K191422Neural Navigator
Soterix Medical, Inc.
HAW
Feb 13, 2020K200079ClearPoint System and Accessories
Mri Interventions, Inc.
HAW
Nov 27, 2019K1929457D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
7D Surgical, Inc., CA
HAW
Nov 1, 2019K191597Stealth Autoguide System, Midas Rex Legend Depth Stop System
Medtronic Navigation, Inc.
HAW
Sep 6, 2019K190250Microscope Navigation
Brainlab AG, DE
HAW
Aug 7, 2019K1832767D Surgical System
7D Surgical, Inc., CA
HAW
Aug 1, 2019K190887Leksell Vantage Stereotactic System
Elekta Instrument AB, SE
HAW
Jul 31, 2019K190672StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
Medtronic Navigation, Inc.
HAW
Jul 14, 2019K183325Modus Nav
Synaptive Medical, Inc., CA
HAW
Jun 21, 2019K191400Voyager Trajectory Array Guide (V-TAG)
Mri Interventions, Inc.
HAW
Feb 7, 2019K182417ROSA ONE Brain Application
Medtech S.A, FR
HAW
Jan 29, 2019K182000AQrate Robotic Assistance System
Globus Medical, Inc.
HAW
Aug 8, 2018K1810417D Surgical System Cranial Application
7D Surgical, Inc., CA
HAW
Jul 26, 2018K181706neuromate Gen III
Renishaw Mayfield Sarl, FR
HAW
Jul 23, 2018K180854Voyager Trajectory Array Guide (V-TAG)
Voyager Therapeutics, Inc.
HAW
Apr 24, 2018K180206neuromate Gen III
Renishaw Mayfield Sarl, FR
HAW
Mar 28, 2018K172444ROSA BRAIN (v3.0.0.5)
Medtech S.A, FR
HAW
Mar 1, 2018K172820Microscope Navigation Software
Brainlab AG, DE
HAW
Sep 15, 2017K171123Leksell Vantage Stereotactic System
Elekta Instrument AB, SE
HAW
Sep 15, 2017K163666neuro inspire
Rensihaw Plc, GB
HAW
Sep 14, 2017K163209Fiagon Navigation System
Fiagon GmbH, DE
HAW
Sep 1, 2017K163439NaviENT
Claronav, Inc., CA
HAW
Apr 21, 2017K162655StealthConnect Remote Viewing, Planning and Collaboration System
Medtronic Navigation, Inc.
HAW
Mar 31, 2017K162309StealthStation S8 System Platforms and StealthStation Cranial Software
Medtronic Navigation, Inc.
HAW
Feb 22, 2017K162929Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryke
Stryker Corporation, DE
HAW
Dec 30, 2016K162604Cranial Reducing Tubes
Medtronic Navigation, Inc.
HAW
Dec 6, 2016K160811CRW STEREOTACTIC SYSTEM
Integra LifeSciences Corporation
HAW
Sep 14, 2016K153660StealthStation System with Cranial Software
Medtronic Navigation, Inc.
HAW
Jul 13, 2016K152764EXACTECH GPS
Blue Ortho, FR
HAW
Jun 24, 2016K160523BrightMatter Guide with BrightMatter Pointer
Synaptive Medical, Inc., CA
HAW
Apr 1, 2016K151156Fiagon Navigation System
Fiagon GmbH, DE
HAW
Mar 30, 2016K153281BrightMatter Guide with Surface Trace Registration
Synaptive Medical, Inc., CA
HAW
Mar 17, 2016K160434ClearPoint System
Mri Interventions, Inc.
HAW
Mar 2, 2016K152558Leksell Stereotactic System, Injection/ Aspiration Needle Kit
Elekta Instrument AB, SE
HAW
Dec 18, 2015K151359ROSA Brain
Medtech S.A, FR
HAW
Oct 30, 2015K143420SYMBIS Surgical System
Imris, Inc.
HAW
Oct 21, 2015K142505ClearPoint System
Mri Interventions, Inc.
HAW
Jul 8, 2015K150301NavSuite3 Kit
Stryker Leibinger GmbH & Co. KG - Navigation, DE
HAW
Jun 11, 2015K150216Synergy Cranial
Medtronic Navigation, Inc.
HAW
Apr 13, 2015K143241MDT Navigable Brain Biopsy Cannula
Izi Medical Products, LLC
HAW
Apr 2, 2015K142024BRIGHTMATTER NAVIGATION SYSTEM
Synaptive Medical, Inc., CA
HAW
Mar 25, 2015K141833STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
Medtronic Navigation, Inc.
HAW
Mar 20, 2015K142344DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System
Izi Medical Products, LLC
HAW
Feb 27, 2015K141559V-GUIDE FOR VENTRICULOSTOMIES
Arc Surgical, LLC
HAW
Dec 5, 2014K140705NAVIGABLE BRAIN BIOPSY CANNULA SET
Izi Medical Products
HAW
Jul 25, 2014K133444STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
Medtronic Navigation, Inc.
HAW

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