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)
Top companies in HAW
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2018 | FHC, Inc. microTargeting" Drive System, Product Number 66-ZD-MD-01 Terminated |
HAW | K011775 |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System, Product Number 66-ZD-MD Terminated |
HAW | K011775 |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System, Product Number MT-DS-01 Terminated |
HAW | K011775 |
| May 10, 2018 | FHC, Inc. microTargeting" Drive System, Product Number MT-DS Terminated |
HAW | K011775 |
| May 8, 2018 | MEDTECH 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 |
HAW | K101791 |
| Nov 16, 2017 | Brainlab AG Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left Terminated |
HAW | K070106 |
| Oct 16, 2017 | Stryker 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 |
HAW | K012380 |
| Jun 26, 2017 | Medtronic Navigation, Inc. Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. Terminated |
HAW | K050438 |
| May 12, 2017 | Orthosoft, Inc. dba Zimmer CAS Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument Terminated |
HAW | K060336 |
| May 12, 2017 | Orthosoft, Inc. dba Zimmer CAS Navitrack System - OS Knee Universal, Stereotaxic instrument Terminated |
HAW | K060336 |
| May 8, 2017 | Orthosoft, Inc. dba Zimmer CAS NDI P7 Position Sensor, Stereotaxic Instrument Terminated |
HAW | K071929 |
| May 1, 2017 | Zimmer 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 |
HAW | K172444 |
| Mar 27, 2017 | Zimmer 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 |
HAW | K151359 |
| Jan 11, 2017 | Medtronic 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 |
HAW | K141833 |
| Oct 11, 2016 | Zimmer 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 |
HAW | K151359 |
| Jul 29, 2016 | Zimmer Biomet, Inc. ROSA BRAIN 3.0.0 Terminated |
HAW | K151359 |
| Jul 20, 2016 | Zimmer 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 |
HAW | K151359 |
| Jul 18, 2016 | Medtronic 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 |
HAW | K001284 |
| Jul 18, 2016 | Medtronic 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 |
HAW | K050438 |
| Jul 18, 2016 | Medtronic 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 |
HAW | K001284 |
| Jul 18, 2016 | Medtronic 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 |
HAW | K992927 |
| Jul 18, 2016 | Medtronic 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 |
HAW | K050438 |
| May 27, 2016 | Zimmer 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 |
HAW | K101791 |
| Apr 8, 2016 | Zimmer Biomet, Inc. ROSA Surgical Device 2.5.8 Terminated |
HAW | K101791 |
| Feb 22, 2016 | Medtronic 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 |
HAW | K003201 |
| Jan 20, 2016 | Zimmer 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 |
HAW | K092239 K101791 |
| Jan 19, 2016 | Brainlab 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 |
HAW | K092467 |
| Dec 23, 2015 | Synaptive 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 |
HAW | K142024 |
| Nov 17, 2015 | Brainlab 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 |
HAW | K070106 |
| Oct 6, 2015 | Integra 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 |
HAW | K944463 |
| Sep 30, 2015 | Medtronic 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 |
HAW | K050438 |
| Aug 18, 2015 | Brainlab 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 |
HAW | K100038 |
| Aug 3, 2015 | Medtronic 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 |
HAW | K971247 |
| Aug 3, 2015 | Medtronic 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 |
HAW | K971247 |
| Jul 16, 2015 | Northern 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 |
HAW | K100038 |
| Jul 16, 2015 | Northern 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 |
HAW | K100038 |
| Jun 26, 2015 | Medtronic 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 |
HAW | None listed |
| Jun 16, 2015 | Stryker 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 |
HAW | K022365 |
| Jun 12, 2015 | Medtronic 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 |
HAW | K972398 |
| Nov 26, 2014 | Mazor 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 |
HAW | K120812 |
| Nov 6, 2014 | Zimmer Biomet, Inc. ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments. Terminated |
HAW | K092239 K101791 |
| Sep 5, 2014 | Zimmer 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 |
HAW | K092239 K101791 |
| Aug 13, 2014 | Brainlab 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 |
HAW | K070106 |
| Jul 25, 2014 | Medtronic 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 |
HAW | K022100 |
| Jun 4, 2014 | Zimmer 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 |
HAW | K092239 K101791 |
| Jun 4, 2014 | Stryker 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 |
HAW | None listed |
| Jun 4, 2014 | Stryker 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 |
HAW | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. UPGRD PRGM 9734638 ADD AxiEM NAVIGATION Terminated |
HAW | K001284 K012937 +4 |
| May 9, 2014 | Medtronic Navigation, Inc. TUMOR RESECTION KIT 9733608 SKULL MOUNT Terminated |
HAW | K001284 K012937 +4 |
| May 9, 2014 | Medtronic Navigation, Inc. TUMOR RESECTION KIT 9733607 NON-INVASIVE Terminated |
HAW | K001284 K012937 +4 |
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