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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

DateFirm and productCodeLinked 510(k)
May 10, 2018FHC, Inc.
microTargeting" Drive System, Product Number 66-ZD-MD-01
Terminated
HAWK011775
May 10, 2018FHC, Inc.
microTargeting" Drive System, Product Number 66-ZD-MD
Terminated
HAWK011775
May 10, 2018FHC, Inc.
microTargeting" Drive System, Product Number MT-DS-01
Terminated
HAWK011775
May 10, 2018FHC, Inc.
microTargeting" Drive System, Product Number MT-DS
Terminated
HAWK011775
May 8, 2018MEDTECH SAS
ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positionin
Terminated
HAWK101791
Nov 16, 2017Brainlab AG
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
Terminated
HAWK070106
Oct 16, 2017Stryker Instruments Div. of Stryker Corporation
The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of butto
Terminated
HAWK012380
Jun 26, 2017Medtronic Navigation, Inc.
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Terminated
HAWK050438
May 12, 2017Orthosoft, Inc. dba Zimmer CAS
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument
Terminated
HAWK060336
May 12, 2017Orthosoft, Inc. dba Zimmer CAS
Navitrack System - OS Knee Universal, Stereotaxic instrument
Terminated
HAWK060336
May 8, 2017Orthosoft, Inc. dba Zimmer CAS
NDI P7 Position Sensor, Stereotaxic Instrument
Terminated
HAWK071929
May 1, 2017Zimmer Biomet, Inc.
ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
Terminated
HAWK172444
Mar 27, 2017Zimmer Biomet, Inc.
MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (
Terminated
HAWK151359
Jan 11, 2017Medtronic Navigation, Inc.
AxIEM Touch N Go Pointer Probe. Model Number: 9735318. Placed in a 30mil PETG tray sealed with a Tyvek lid and then placed in a shelf carton.
Terminated
HAWK141833
Oct 11, 2016Zimmer Biomet, Inc.
ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biop
Terminated
HAWK151359
Jul 29, 2016Zimmer Biomet, Inc.
ROSA BRAIN 3.0.0
Terminated
HAWK151359
Jul 20, 2016Zimmer Biomet, Inc.
ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments
Terminated
HAWK151359
Jul 18, 2016Medtronic Navigation, Inc.
MACH AxiEM Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as a
Terminated
HAWK001284
Jul 18, 2016Medtronic Navigation, Inc.
MACH Cranial Treon. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid
Terminated
HAWK050438
Jul 18, 2016Medtronic Navigation, Inc.
Fusion ENT Application. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an
Terminated
HAWK001284
Jul 18, 2016Medtronic Navigation, Inc.
S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid f
Terminated
HAWK992927
Jul 18, 2016Medtronic Navigation, Inc.
Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid
Terminated
HAWK050438
May 27, 2016Zimmer Biomet, Inc.
ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicat
Terminated
HAWK101791
Apr 8, 2016Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8
Terminated
HAWK101791
Feb 22, 2016Medtronic Navigation, Inc.
BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during surgical procedures as an instrument guide holde
Terminated
HAWK003201
Jan 20, 2016Zimmer Biomet, Inc.
Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Ed
Terminated
HAWK092239
K101791
Jan 19, 2016Brainlab AG
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localizatio
Terminated
HAWK092467
Dec 23, 2015Synaptive Medical, Inc.
Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planni
Terminated
HAWK142024
Nov 17, 2015Brainlab AG
BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localizat
Terminated
HAWK070106
Oct 6, 2015Integra LifeSciences Corp.
Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra CRW Precision Arc Stereotactic System.
Terminated
HAWK944463
Sep 30, 2015Medtronic Navigation, Inc.
P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA STANDARD; and P/N: 9734373, SCREWDRIVER 9734373 SOLE
Terminated
HAWK050438
Aug 18, 2015Brainlab AG
Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for preci
Terminated
HAWK100038
Aug 3, 2015Medtronic Navigation, Inc.
Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. Th
Terminated
HAWK971247
Aug 3, 2015Medtronic Navigation, Inc.
Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Nee
Terminated
HAWK971247
Jul 16, 2015Northern Digital Inc.
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus ena
Terminated
HAWK100038
Jul 16, 2015Northern Digital Inc.
NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus
Terminated
HAWK100038
Jun 26, 2015Medtronic Navigation, Inc.
Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set
Terminated
HAWNone listed
Jun 16, 2015Stryker Instruments Div. of Stryker Corporation
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a p
Terminated
HAWK022365
Jun 12, 2015Medtronic Navigation, Inc.
Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments
Terminated
HAWK972398
Nov 26, 2014Mazor Robotics Ltd
Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instrume
Terminated
HAWK120812
Nov 6, 2014Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Terminated
HAWK092239
K101791
Sep 5, 2014Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instru
Terminated
HAWK092239
K101791
Aug 13, 2014Brainlab AG
Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passi
Terminated
HAWK070106
Jul 25, 2014Medtronic Neuromodulation
Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and impl
Terminated
HAWK022100
Jun 4, 2014Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative pl
Terminated
HAWK092239
K101791
Jun 4, 2014Stryker Instruments Div. of Stryker Corporation
The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor).
Terminated
HAWNone listed
Jun 4, 2014Stryker Instruments Div. of Stryker Corporation
The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms
Terminated
HAWNone listed
May 9, 2014Medtronic Navigation, Inc.
UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
Terminated
HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
TUMOR RESECTION KIT 9733608 SKULL MOUNT
Terminated
HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
TUMOR RESECTION KIT 9733607 NON-INVASIVE
Terminated
HAWK001284
K012937 +4

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