FDA.reportPublic FDA data

Electromagnetic/optical surgical navigation/tracking system

Definition
A mobile assembly of electrically-powered devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures, commonly with respect to pre-acquired images and/or real-time data [e.g., computed tomography (CT), ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, an EM field generator, a camera, and sensors/spatial markers for attachment to the patient and instruments for position/movement tracking. It is used for multiple procedures (e.g., craniotomy) in various fields [e.g., ear/nose/throat (ENT), craniomaxillofacial (CMF) surgery].
GUDID devices
119
Last updated
2026-09-04 23:12:54

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04056481001018Disposable Trocar Insert Pedicle Access Needle (1 pcs.)Brainlab SE55846-012016-09-15
04056481001049Guide Tube Pedicle Access Needle (1.8 mm)Brainlab SE55844A2016-09-15
04056481001230INSTRUMENT TRACKING ARRAY SPINE & TRAUMA (SIZE L)Brainlab SE55830-292016-09-15
04056481001247INSTRUMENT TRACKING ARRAY SPINE & TRAUMA 4-MARKERBrainlab SE55830-272016-09-15
04056481001254INSTRUMENT TRACKING ARRAY SPINE & TRAUMA (SIZE ML)Brainlab SE55830-25A2016-09-15
04056481001261INSTRUMENT TRACKING ARRAY SPINE & TRAUMA 3-MARKER)Brainlab SE55830-20A2016-09-15
04056481001407Starlink Suction Tube Olive-Tip 45° Angled 10 FRBrainlab SE55790A2016-09-15
04056481001414Starlink Suction Tube Frazier-Tip 45° Angled 8 FRBrainlab SE55790-752016-09-15
04056481001421Starlink Suction Tube Frazier-Tip 45° Angled 10 FRBrainlab SE55790-702016-09-15
04056481001438Starlink Suction Tube Frazier-Tip 70° Angled 10 FRBrainlab SE55790-652016-09-15
04056481001452Starlink Suction Tube Frazier-Tip 70° Angled 8 FRBrainlab SE55790-552016-09-15
04056481001469Starlink Suction Tube Olive-Tip 70° Angled 8 FRBrainlab SE55790-50A2016-09-15
04056481001551Starlink Suction Tube Olive-Tip 45° Angled 8 FRBrainlab SE55790-05A2016-09-15
04056481002459Skull Reference BaseBrainlab SE52129B2016-09-15
04056481002473Skull Reference ArrayBrainlab SE52122A2016-09-15
04056481002503Patient Reference Attachment Arm for Skull ClampBrainlab SE52001F2016-09-15
04056481002725Instrument Calibration MatrixBrainlab SE41874B2016-09-15
04056481004811EM Registration PointerBrainlab SE18099-232016-09-15
04056481004866Skull Reference Base EMBrainlab SE18099-062016-09-15
04056481004927EM PointerBrainlab SE18099-02C2016-09-15
04056481005658Dispos. Clip-On Remote ControlBrainlab SE531512016-09-15
04056481005955Bone Fixator 2-Pin X-PressBrainlab SE524292016-09-15
04056481006051Patient Reference T-Adapter for Skull ClampBrainlab SE520032016-09-15
04056481006297Patient Reference Attachment for Skull ClampBrainlab SE417342016-09-15
04056481006303Patient Reference Array for Skull ClampBrainlab SE417252016-09-15
04056481113926C-ARM ADAPTER ZIEHM RFD 3D LEFTBrainlab SE19154-042018-08-03
04056481113933C-ARM ADAPTER ZIEHM RFD 3D RIGHTBrainlab SE19154-032018-08-24
04056481113940C-ARM REFERENCE UNIT LEFTBrainlab SE19154-022018-02-13
04056481113957C-ARM REFERENCE UNIT RIGHTBrainlab SE19154-012018-02-13
04056481140342C-ARM ADAPTER SIEMENS CIOS SPIN LEFTBrainlab SE19154-052018-05-02
04056481140359C-ARM ADAPTER SIEMENS CIOS SPIN RIGHTBrainlab SE19154-062018-05-02
04056481140410EM Short PointerBrainlab SE18099-272019-07-16
04056481140847Buzz Navigation (Ceiling Mounted)Brainlab SE157062018-10-31
04056481141233Cirq Robotic Instrument Holder SpineBrainlab SE563012022-12-27
04056481141240Cirq Robotic Tracking Array Spine 10.0Brainlab SE563022022-12-27
04056481141257Cirq Robotic Depth Tracking Array blackBrainlab SE563032022-12-27
04056481141264Cirq Robotic Depth Tracking Array beigeBrainlab SE563042022-12-27
04056481141271Alignment Guide Tube Spine 2.4/10.00Brainlab SE563242022-12-23
04056481141288Alignment Guide Tube Spine 2.6/10.00Brainlab SE563262022-12-27
04056481141295Alignment Guide Tube Spine 3.2/10.00Brainlab SE563322022-12-27
04056481141301Alignment Depth Control SpineBrainlab SE563502022-12-23
04056481141318Alignment Trocar Spine 2.4Brainlab SE56324-242022-12-27
04056481141325Alignment Trocar Spine 2.6Brainlab SE56326-262022-12-27
04056481141332Alignment Trocar Spine 3.2Brainlab SE56332-322022-12-27
04056481141349Alignment Trocar Spine 6.0/10.0Brainlab SE563102022-12-27
04056481141462AUTO-REG MATRIX iMRIBrainlab SE19208-012020-01-08
04056481141561Cirq Robotic Tracking Array Cranial 7.5Brainlab SE564022021-11-24
04056481141578Cirq Robotic Instrument Holder CranialBrainlab SE564012021-11-24
04056481143503Kick 2 Navigation StationBrainlab SE182002021-05-31
04056481143725Kick 2 Navigation Station EMBrainlab SE182022022-09-30
04056481143817Alignment Bone Anchor Cranial 2.1/3.8Brainlab SE564242023-09-18
04056481143848Cranial NavigationBrainlab SE4.12023-08-02
04056481143923Registration Fluoro 3DBrainlab SE1.52021-11-30
04056481143930C-ARM ADAPTER GE OEC 3D LEFTBrainlab SE19154-072021-12-01
04056481143947C-ARM ADAPTER GE OEC 3D RIGHTBrainlab SE19154-082021-12-01
04056481143954Spine & Trauma NavigationBrainlab SE2.02022-05-31
04056481143985Mixed Reality Spine NavigationBrainlab SE1.02025-05-31
04056481144395Alignment Guide Tube Cranial 2.5/7.5Brainlab SE564072023-09-18
04056481144401Alignment Guide Tube Cranial 4.0/7.5Brainlab SE564112023-09-18
04056481144418Alignment Guide Tube Cranial 3.8/7.5Brainlab SE564232023-09-18
04056481144432Alignment Reduction Tube Cranial 2.5/4.0Brainlab SE564152023-09-18
04056481144470Alignment Software SpineBrainlab SE2.02022-09-30
04056481144487Alignment Software CranialBrainlab SE2.02023-09-18
04056481144500Curve Navigation 17700Brainlab SE177012023-05-22
04056481144630Ultrasound NavigationBrainlab SE1.22024-04-26
04056481144685Disposable Skull Reference Bone Fixation Screw 1.5 mm x 6 mmBrainlab SE521722023-05-05
04056481144692Disposable Skull Reference Drill Bit 1.1 mm for Bone Fixation ScrewBrainlab SE521732023-05-05
04056481144708Skull Reference Screwdriver HandleBrainlab SE521742023-05-05
04056481144715Skull Reference Screwdriver BladeBrainlab SE521752023-05-05
04056481144845Automatic Registration iMRIBrainlab SE1.12023-11-20
04056481144906Spine &Trauma NavigationBrainlab SE3.02024-11-14
04056481145101Automatic RegistrationBrainlab SE2.62023-09-22
04056481145200DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS)Brainlab SE549292023-10-17
04056481145392DRAPELINK REF ADAPTER AUTO-REG IMRIBrainlab SE19208-02A2023-10-16
04056481145514Z-touch Laser Registration PointerBrainlab SE18370-10A2025-02-13
04056481145620Alignment Reduction Tube Cranial 8.0 mm / 10.0 mmBrainlab SE564162025-02-24
04056481145637Alignment Guide Tube Cranial 4.9 mm / 8.0 mmBrainlab SE564172025-02-24
04056481145828Microscope NavigationBrainlab SE1.72025-06-11
04056481145903Alignment Bone Anchor Cranial 2.1 mm / 4.9 mmBrainlab SE564182025-02-24
04056481146047Cirq Robotic Tracking Array 10.0Brainlab SE56302A2025-02-24