ClearanceBrief
Panels › Neurology › Product code HAW · Class 2

Neurological Stereotaxic Instrument

Regulation 882.4560

6510(k)s in 12 months (427 all time)
7recalls in 12 months (202 all time)
199recalls that name a 510(k)
Get daily alerts for HAWSample briefCSV

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
DateFirm and productCodeLinked 510(k)
May 9, 2014Medtronic Navigation, Inc.
TUMOR RES. PACK 9733553 AxiEM S.M.
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
TRAJ GUIDE KIT, 9733066, BIOPSY, INT
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
SPHERES 8801075 5/TRAY 12PK
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
SPHERES 8801071 1/TRAY 12PK
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
SHUNT KIT 9733605 NON-INVASIVE
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
PIN, 9733236, 150MM, STERILE, PERC REF
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
PIN, 9733235, 100MM, STERILE, PERC REF
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
PATIENT TRACKER 9733534XOM ENT 1PK
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
PACK 9731975 TUMOR RESECTION AXIEM CR
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
KIT, 9731427, THORACIC TACTILE PROBES
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
INSTRUMENT TRACKER 9733533XOM ENT 1PK
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
INST 9731132 KIT CR REF FRAME DRIVER 5PK
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
ENT PRGM 9734636 ADD FUSION NAV AxiEM
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
DISP 9730951 STRL SPHERE, 5PK INSERT
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
DISP 9730950 STRL SPHERE, 1 PK INSERT
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
BIT 9733516 2.9mm DRILL STERILE
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
BIOPSY NEEDLE KIT, 9733068, PASSIVE
Terminated		 HAWK001284
K012937 +4
May 9, 2014Medtronic Navigation, Inc.
BAG 9732315 MOUSE STERILE 15 PK
Terminated		 HAWK001284
K012937 +4
Apr 17, 2014Brainlab AG
Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
Terminated		 HAWK070106
Feb 14, 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
Terminated		 HAWK092239
K101791
Feb 10, 2014Brainlab AG
BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor sy
Terminated		 HAWK053159
Dec 18, 2013Zimmer 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 instr
Terminated		 HAWK092239
K101791
Nov 4, 2013Elekta, Inc.
Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.
Terminated		 HAWK011255
Aug 13, 2013Medtronic Navigation, Inc.
StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures.
Terminated		 HAWK992927
Feb 10, 2013Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8
Terminated		 HAWK092239
K101791
Feb 5, 2013Zimmer 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 inst
Terminated		 HAWK092239
K101791
Nov 29, 2012Medtronic Navigation, Inc.
The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assi
Terminated		 HAWK050438
Sep 20, 2012Integra LifeSciences Corporation
Integra HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only o
Terminated		 HAWK944463
Sep 20, 2012Integra LifeSciences Corporation
Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a targ
Terminated		 HAWK944463
Jul 11, 2012GE OEC Medical Systems, Inc
The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used in conjunction with the Axcess Cranial Tri-Pin Kit. The Axce
Terminated		 HAWK051734
Apr 19, 2012Zimmer 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 instr
Terminated		 HAWK092239
K101791
Mar 8, 2012Medtronic Navigation, Inc.
Right Long Tactile Probe, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable handheld instruments used in spine surgeries for preparation of the pedicle. These instruments are used
Terminated		 HAWK990214
Mar 8, 2012Medtronic Navigation, Inc.
Left Long Tactile Probe, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used
Terminated		 HAWK990214
Nov 30, 2011Elekta, Inc.
Stereotactic Circular Collimator Product Usage: This device is intended to hold a patient's head in a fixed position and to localize and center the output of a linear accelerator (UNAC) to allow rad
Terminated		 HAWK011255
Oct 3, 2011Medtronic Navigation, Inc
Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instrument
Terminated		 HAWK990214
Oct 3, 2011Medtronic Navigation, Inc
Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments
Terminated		 HAWK990214
Jul 11, 2011Medtronic Navigation, Inc.
DICOM Query/Retrieve, version 1.1.4. Individual part # 9733808, or as part of a system order, DICOM Q/R Software Kit, part # 9733933. DICOM Query/Retrieve software is installed on Medtronic StealthSta
Terminated		 HAWK050438
Mar 4, 2011Medtronic Navigation, Inc
Polaris Spectra Position Sensor Unit, a component of the StealthStation S7 System, Medtronic Navigation, Louisville, CO 80027. The Polaris Spectra Position Sensor Unit (PSU) is the component of the S
Terminated		 HAWK050438
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - SALES DEMO, Part number 81-81018. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include
Terminated		 HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - SALES DEMO, Part number 81-81016. provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle features include com
Terminated		 HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - SpineMap(TM) 3D - Sales Demo SOFTWARE, Part number 81-80045. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three
Terminated		 HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - OrthoMap 3D (Sales Demos), Part number 81-81016. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle fe
Terminated		 HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - OrthoMap 3D - Planning, Part number 6005-651-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle f
Terminated		 HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - OrthoMap 3D - Enable, Part number 6005-650-300. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle fea
Terminated		 HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - OrthoMap 3D Module, Part number 6005-650-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle featu
Terminated		 HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - SpineMap 3D - Planning, Part number 6002-651-000. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle f
Terminated		 HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - OrthoMap 3D - Enable, Part number 6002-650-300. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle fea
Terminated		 HAWK062640
Feb 25, 2011Stryker Instruments Division of Stryker Corporation
Stryker Navigation System - SpineMap 3D - Upgrade, Part number 6002-650-100. It provides precise stereostatic determination of surgical targets using stereostatic methodology. The three principle fe
Terminated		 HAWK062640

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.