Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instrumentsSurgical navigation instruments

Surgical navigation instruments - hardware accessories

EMDN code Z12011480

27 manufacturers, 309 models including 306 on the market, 8 countries

On the market in Models on the market only Manufacturer country

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Manufacturers registered in Europe (EUDAMED) 27

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Brainlab FDA	Germany	ADAPTER FOR SURGICAL MOTOR SYSTEM ADAPTER LONG FOR PATIENT REFERENCE CLAMP2 refs ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAY 52419A ADHESIVE REFLECTIVE FLAT MARKERS (10 PCS) 4056481AdFlatMarker2T Alignment Arm2 refs 106 others Alignment Bone Anchor Cranial 2.1/3.8 Alignment Depth Control Spine Alignment Guide Tube Cranial 2.5/7.53 refs Alignment Reduction Tube Cranial 2.5/4.0 Alignment Trocar Spine 2.43 refs AUTO-REG MATRIX iMRI2 refs AWL (3,0 MM) FOR OPEN SURGERY3 refs Bone Fixator "1-Pin", X-Press Size-L Spine & Trauma 3D Instruments93/42 Bone Fixator "1-Pin", X-Press Size-M Spine & Trauma 3D Instruments93/42 Bone Fixator "1-Pin", X-Press Size-S Spine & Trauma 3D Instruments93/42 BONE FIXATOR 2-PIN X-PRESS Buzz Navigation (Ceiling-Mounted) C-ARM ADAPTER FOR GE OEC 3D LEFT3 refs CALIBRATION PHANTOM INTRAOPERATIVE CT2 refs Cirq Arm System 2.0 Cirq Instrument Holder Cirq Instrument Holder Module Cirq Robotic Alignment Module CIRQ ROBOTIC BIOPSY BONE ANCHOR CRANIAL93/42 CIRQ ROBOTIC BIOPSY GUIDE TUBE CRANIAL93/42 Cirq Robotic Depth Tracking Array beige2 refs Cirq Robotic Instrument Holder Cranial2 refs Cirq Robotic Tracking Array 10.03 refs Curve Navigation Curve Navigation 17700 DISP FIXATION PIN 4.0 X 125 MM (10 PCS) DOUBLE OPEN-END WRENCH (10 X 14 MM) Drill Guide Tube (4.5 mm) 51839-453 refs DRILL DEPTH STOP CRANIAL 2.53 refs Drill Guide Handle 518393 refs Drill Guide Compact Handle 4 Markers3 refs Drill Guide Tissue Protection Sleeve 10mm Spine & Trauma 3D Instruments93/42 Drill Guide Trocar Tube 5mm X 180mm Spine & Trauma 3D Instruments93/42 Drill Guide Tube 2.4 X 150mm Spine & Trauma 3D Instruments93/42 Drill Guide Tube 2.6mm X 150mm Spine & Trauma 3D Instruments93/42 Drill Guide Tube 2.6mm X 200mm Spine & Trauma 3D Instruments93/42 Drill Guide Tube 3.0 X 150 mm Spine & Trauma 3D Instruments93/42 Drill Guide Tube 3.2mm X 150mm Spine & Trauma 3D Instruments93/42 Drill Guide Tube 3.2mm X 200mm Spine & Trauma 3D Instruments93/42 Drill Guide Tube 4.5mm X 200mm Spine & Trauma 3D Instruments93/42 EM Instrument Tracker EM Patient Reference EM Pointer2 refs EM Registration Pointer Eraser Pointer Tip (Curved)93/42 Eraser Pointer Tip (Straight)93/42 Gauge for Softouch Registration Pointer GUIDE TUBE PEDICLE ACCESS NEEDLE (1.8 MM) HANDHELD REGISTRATION DEVICE FLUORO 2D Spine & Trauma 3D Instruments93/42 HANDLE FOR MULTIPLE TIP POINTER HANDLE GEARSHIFT FOR OPEN SURGERY2 refs HEX SCREW-DRIVER 2.5 MM HEX SCREWDRIVER BALL-END (2.5 MM)3 refs INSTRUMENT ADAPTER CLAMP STARLINK FOR CYLINDRICAL INSTRUMENTS3 refs INSTRUMENT CALIBRATION MATRIX 41874B INSTRUMENT TRACKING ARRAY S&T (SIZE L)3 refs INSTRUMENT TRACKING ARRAY STARLINK SIZE L3 refs Kick 2 Navigation Station EM, Kick® Navigation, Kick2® Navigation, Kick Navigation EM, Kick Navigation System EM2 refs MICROSCOPE ADAPTER FOR TRACKING ARRAY (LEICA)2 refs MICROSCOPE TRACKING ARRAY Pat. Ref. Array for Skull Clamp3 refs PATIENT REFERENCE ARRAY FOR DISPOSABLE HEADBAND PATIENT REFERENCE ARRAY SPINE & TRAUMA3 refs PATIENT REFERENCE ROD-CLAMP SPINE & TRAUMA3 refs Pointer Sharp-Tip-Extended Spine & Trauma 3D Instruments93/42 Pointer Tip (Offset 0°, length 100 mm)93/42 Pointer Tip (Offset 0°, length 150 mm)93/42 Pointer Tip (Offset 0°, length 60 mm)93/42 Pointer Tip (Offset 30°, length 95 mm)93/42 Pointer, Blunt Tip93/42 Quip Instrument Adapter 45° Angled 582103 refs Quip Link Instrument Tracking Array For 3 Marker Spheres L 581933 refs RADIOLUCENT DRAPELINK BASE SHORT3 refs RADIOLUCENT DRAPELINK PATIENT REFERENCE ARRAY REFLECTIVE DISKS FLUORO KIT REV2-21 PCS REGISTRATION MATRIX FOR IMRI HEAD HOLDER (NORAS) Skull Reference Array Skull Reference Base2 refs Skull Reference Screwdriver Blade2 refs SOFTOUCH POINTER (REV 3)93/42 Spine Reference Array (4-Marker) Spine & Trauma 3D Instruments93/42 SPINE REFERENCE CLAMP (CARBON) Spine & Trauma 3D Instruments93/42 Suction MS (CH10) Starlink Frazier93/42 Suction MS (CH8) Starlink93/42 Suction MS (CH8) Starlink Frazier93/42 Suction STD (CH10) Starlink93/42 Suction STD (CH10) Starlink Frazier93/42 Suction STD (CH8) Starlink93/42 Suction STD (CH8) Starlink Frazier93/42 Trocar Insert 5mm93/42 Trocar Reduction Sleeve 2.0mm Spine & Trauma 3D Instruments93/42 Trocar Reduction Sleeve 2.8mm Spine & Trauma 3D Instruments93/42 Trocar Reduction Sleeve 3.2mm Spine & Trauma 3D Instruments93/42 Trocar Sharp Tip 2.4 mm Spine & Trauma 3D Instruments93/42 Trocar Sharp Tip 2.6 mm Spine & Trauma 3D Instruments93/42 Trocar Sharp Tip 2.6mm (200mm) Spine & Trauma 3D Instruments93/42 Trocar Sharp Tip 3.2 mm Spine & Trauma 3D Instruments93/42 Trocar Sharp Tip 3.2mm (200mm) Spine & Trauma 3D Instruments93/42 ULTRASOUND NAVIGATION ADAPTER (ALOKA C42K) 41860-423 refs ULTRASOUND REGISTRATION PHANTOM V-Inset GE Headholder Kit3 refs Varioguide Array 4-Marker3 refs Z-touch Laser Registration Pointer Z-Touch Rev293/42 Registration Matrix CT – Minimally Invasive (Cranial and Spine)93/42 (no longer marketed) Registration Matrix CT – Open Surgery (Spine)93/42 (no longer marketed) Registration Matrix CT – Small Incision (Spine)93/42 (no longer marketed)	I, IIa, IIb MDR, 93/42	regulatory.affairs@brainlab.com EUDAMED record Report an error
Medtronic FDA EU representative : Medtronic B.V. (Netherlands)	United States	3DFL Tracker and Adapter3 refs 9736093 Ziehm Integration Kit Active Wireless Tracker ARM 9734999 RADIOLUCENT KIT Autoguide Drill Guides3 refs 57 others Autoguide Guiding Inserts Autoguide Guiding Joints Autoguide Headclamp Adaptor Autoguide Height Guides2 refs Autoguide Obturators2 refs Autoguide Positioning Arm Autoguide Reducing Tubes3 refs Autoguide Surgical Instruments Autoguide System3 refs Autoguide Tapping Tubes Autoguide Tracker Autopilot Trajectory Guides3 refs Clamping Rings CRANIAL KIT 9735030 STEALTHAIR ICT Cranial Referencing3 refs DG KIT 9732221 SHORT DRILL GUIDE EM Segment Tracker EM Spine Reference Frame Tracker EM Tracker Driver GEHC TRNSDCR and Verification2 refs Hybrid Reference Frame INST KIT 9735028 CRANIAL EU ONLY INST SET 9734494 TACTILE PROBES INST SET 9734834 CAPSTONE TRIALS INST SET 9734835 CLYDESDALE TRIALS INST SET 9734836 TLIF/DLIF INSERTER Instrument Handles Interbody Trials3 refs INTF KIT LEICA HUD S8 MAST Dilator & Tracker3 refs Navigated Awls and Probes3 refs Navigated Taps & Drivers4 refs Navlock Instrument Sets Non-Invasive Patient Tracker Ortho Frames3 refs Powerease Adapters2 refs Reducing Tubes3 refs REF KIT 9734990 STEALTHAIR REF FRAME SET REF SET 9735500 SPINE REFRENCING REF SET 9735501 SPINE REF REVISION Reference Frames Robotic Reference Frame Short Bed Rail Adapter SONONAV Mounts Spine Referencing3 refs Spine Stabilization invasive3 refs Spine Stabilization Non-invasive3 refs StealthStation S8 Emitters3 refs SureTrak II3 refs SURETRAK2 961-574 PASSIVE SYSTEM Tactile Probe3 refs Touch-N-Go Pointer Tracker3 refs Universal Drill Guides3 refs UPGRADE SET 9735502 PERC PIN VERTEK 9733936 PASSIVE BIOPSY KIT ZEISS MICROSCOPE Trackers & Accessories3 refs	I, IIa, III MDR	EUDAMED record Report an error
Stryker FDA	Germany	08858250000507RS2 refs 08858250000517RV 08858250000518RX 08858250000522RN 08858250000523RQ 43 others 08858250000524RS 08858250000525RU2 refs 08858250000527RY2 refs 08858250000528S23 refs 08858250000530RM 08858250000531RP 08858250000532RR 08858250000533RT 08858250000535RX2 refs 08858250000538S5 08858250000539S7 08858250000540RQ 08858250000541RS2 refs 08858250000542RU 08858250000544RY2 refs 08858250000545S23 refs 08858250000546S43 refs 08858250000547S63 refs 08858250000548S8 08858250000549SA3 refs 08858250000551RV 08858250000552RX3 refs 08858250000554S3 08858250000558SB 08858250000560RW3 refs 08858250000561RY2 refs 08858250000564S6 08858250000565S82 refs 08858250000566SA 08858250000568SE2 refs 08858250000569SG2 refs 08858250000570RZ2 refs 08858250000571S33 refs 08858250000576SD 08858250000577SF 08858251004549TP3 refs 08858251005719TX2 refs NGENIUS 08858250000526RW2 refs NGENIUS 08858250000537S3 nGenius 08858250000543RW2 refs ORTHOLOCK 08858250000536RZ Stryker VariSpeed 08858251001895TQ TGS 08858250000556S7	I, IIa, III MDR	Website EUDAMED record Report an error
Kico Knee Innovation Pty FDA EU representative : MedEnvoy Global BV (Netherlands)	Australia	[ARVIS - Instruments] Flex Jack [ARVIS - Instruments] Mounts and Adapters3 refs [ARVIS - Instruments] Registration Stylus, Hip and Knee [ARVIS - Instruments] Tracker A, B, C3 refs [ARVIS - Instruments] Tracker D 10 others [ARVIS] Belt Pack2 refs [ARVIS] Eyepiece Assembly2 refs [ARVIS] Flyte Mounting Kit2 refs [ARVIS] Headband2 refs [ARVIS] T7 Adapter Kit2 refs Arvis5 refs ARVIS Instrument - SS8 Mount Kit ARVIS Shoulder Instrument Set 2.0 Mechanical Mount IN-23000 Tracker A, Mechanical2 refs	I, IIa MDR	Website EUDAMED record Report an error
Fiagon FDA	Germany	Adapter for Clipsensor Accessory to RIWOtrack Navigation System / adapter2 refs Adapter for Flexsensor Accessory to RIWOtrack Navigation System / adapter Flexarm Adapter for siderail Accessory to Cube 4D Navigation System / Navigation sensor support, Adapter2 refs Localizer Adhesive Pad Patient reference device for navigation2 refs MapperBridge Accessory to RIWOtrack Navigation System / registration device 6 others MultiPad Accessory to RIWOtrack Navigation System / registration device Navigation Headrest Flat Accessory to Cube4D Navigation System / Navigation sensor support, headrest3 refs PointerShell 3mm Accessory to Cube4D Navigation System / Instrument tracker3 refs RegistrationPointer Accessory to Cube4D Navigation System / Registration device tactile RIWOtrack Clipsensor Accessory to RIWOtrack Navigation System / Instrument tracker2 refs VirtuEye Accessory to Cube4D Navigation system / registration device, non-tactile2 refs	I MDR	Website info@fiagon.com EUDAMED record Report an error
Spineart FDA EU representative : Alpes CN SAS (France)	Switzerland	PERLA NAV. CANNULATED TAP, Ø3.5 (Ø4 SCREW)3 refs PERLA® BRAINLAB NAVIGATION ADAPTOR PERLA® NAV DRILL3 refs PERLA® NAV LOCKING SCREWDRIVER3 refs PERLA® TL CANNULATED CORTICAL SCREWDRIVER SHAFT3 refs 4 others PERLA® TL CORTICAL SCREWDRIVER SLEEVE3 refs PERLA® TL CORTICAL SCREWDRIVER TUBE3 refs PERLA® TL NAV LUMBO-PELVIC NAV. PROBE SQUARE - STRAIGHT PERLA® TL SCREWDRIVER PROTECTION SLEEVE	IIa MDR	Website info@spineart.com EUDAMED record Report an error
Cascination FDA EU representative : CAScination Deutschland GmbH (Germany)	Switzerland	CAS-One IR Accessory Tray A CAS-One IR Aiming Device A CAS-One IR Baseplate A CAS-One IR Cushion A CAS-One IR Guide Arm A 2 others CAS-One IR Platform A CAS-One IR Pointer A	I MDR	Website info@cascination.com EUDAMED record Report an error
Quantum Surgical FDA	France	02-0026 02-0027 30-0004 Navigation probe2 refs NEEDLE HOLDER H123 refs	I MDR	Website EUDAMED record Report an error
ClaroNav FDA EU representative : Emergo Europe B.V. (Netherlands)	Canada	2D C-Arm Calibration Phantom – Large3 refs C-arm Reference Frame-13 refs Microscope Probe 950-NC-MP3 refs Navient Accessories Kit – Cranial2 refs	I MDR	Website info@claronav.com EUDAMED record Report an error
Mininavident EU representative : Axxos GmbH (Germany)	Switzerland	DENADAPT Bien-Air ventilated with cable M1204 DENAMARK M1500 DENAMARK single use M1501 DENAREG M1801	I MDR	Website info@mininavident.com EUDAMED record Report an error
R.A.W	Italy	Needle fiducial - Sensor IR SIR000 Needle fiducial - Sensor U SU000 Patient fiducial - Marker IR MIR000 Patient fiducial - Marker kit MK000	I, IIa MDR	Website quality@endo-sight.it EUDAMED record Report an error
Straumann FDA EU representative : Etkon GmbH (Germany)	Switzerland	Calibration Tool for Straumann® Falcon Probe for Dynamic Navigation FA1900 Straumann® Falcon: Auxiliaries Straumann® Falcon: Registration tool	I MDR	Website info@straumann.com EUDAMED record Report an error
Aesculap FDA	Germany	ORTHOPILOT8 refs ORTHOPILOT 44 refs ORTHOPILOT THA8 refs	I, IIa MDR	Website eudamed@bbraun.com EUDAMED record Report an error
BEC	Germany	guidoo needle guide guidoo needle guide holder guidoo robot tool front	I MDR	Website info@bec-robotics.com EUDAMED record Report an error
Citieffe FDA	Italy	SURGICAL INSTRUMENTS (I) Patient sensor base GH91102 refs SURGICAL INSTRUMENTS (IS) Sensors3 refs	I MDR	Website info@citieffe.com EUDAMED record Report an error
Ergosurg	Germany	Electromagnetic Tracking Unit93/42 Navigation Base Unit Electromagnetic93/42	I 93/42	Website info@ergosurg.com EUDAMED record Report an error
Joimax FDA	Germany	joimax® Intracs® EM Mounting Arm f Field Generator mounting arm + rail clamp joimax® Intracs® EM Mounting Arm f. Patient Mapper mounting arm + rail clamp	I MDR	Website quality@joimax.com EUDAMED record Report an error
NuVasive FDA EU representative : AJW Technology Consulting GmbH (Germany)	United States	NVM5 PULSE3 refs	I MDR	Website EUDAMED record Report an error
Philips FDA EU representative : Philips Medical Systems Nederland B.V. (Netherlands)	United States	20004 PercuNav Ultrasound Tracker3 refs Planar Field Generator with Stand2 refs	I MDR	eudamed@philips.com EUDAMED record Report an error
Stereotaxis FDA EU representative : MDSS GmbH (Germany)	United States	iCONNECT CARTO System Cable iCONNECT Navistar Catheter Cable	I MDR	Info@stereotaxis.com EUDAMED record Report an error
ATLAS medical technologies	Germany	CBCT Model ATL-D-PT002ns	I MDR	Website info@atlas4d.de EUDAMED record Report an error
Blue Ortho FDA	France	GPS Mobile cart3 refs	IIa MDR	Website info@blue-ortho.com EUDAMED record Report an error
Lunghealth EU representative : SUNGO Europe B.V. (Netherlands)	China	EMND001	IIa MDR	info@lunghealth.com.cn EUDAMED record Report an error
Medacta FDA EU representative : Medacta Italia srl (Italy)	Switzerland	Offset adapter - Left2 refs	I MDR	Website info@medacta.ch EUDAMED record Report an error
NICO FDA EU representative : Atlantico Systems, Ltd. (Ireland)	United States	NICO BrainPath	I MDR	Website info@NICOneuro.com EUDAMED record Report an error
Therenva FDA	France	EndoNaut Workstation TS1CA2DS1-2	I MDR	Website contact@therenva.com EUDAMED record Report an error
Tinavi FDA EU representative : MedPath GmbH (Germany)	China	Navigation Tool Kit Tikit-A3003 refs	IIa MDR	info@tinavi.com EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 195

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
FHC, Inc. Present in Europe in other categories	United States	microTargeting™ Insertion Tube with Stylet microTargeting™ Insertion Tube microTargeting™ Insertion Tube Set microTargeting™ Platform microTargeting™ Spacer Tube STar™ Drive Frame Adapter	K121950 (2012)
Elekta Instrument AB	Sweden	Leksell Stereotactic System Leksell Vantage Stereotactic System Leksell Stereotactic System Neurosurgical Instruments Leksell Gamma Knife Perfexion/Icon	K190887 (2019)
PMT CORPORATION	United States	PMT CORPORATION - STEREOTACTIC STEREOTACTIC PMT CORPORATION ACCUNAV®	registered
Mazor Robotics , Ltd. Present in Europe in other categories	Israel	SA Reduction Tube, 10 pack 4mm x 120mm Schanz Screw, Qty: 10 SA 3.0mm Short Drill, 10 pack Brain Disposable Kit Drill Guide Anchor, 10 pack Arm 4	K120812 (2012)
Medtech S.A Present in Europe in other categories	France	MAYFIELD HEAD HOLDER ADAPTOR STORZ 28160 G ADAPTOR SEEG SST DRILL ADAPTOR Ø3.2MM SEEG SST DRILL ADAPTOR Ø2.15MM LEKSELL FRAME REGISTRATION PLATES SEEG SST DRILL ADAPTOR Ø2.55MM	K231103 (2023)
Elekta Solutions AB Present in Europe in other categories	Sweden	Leksell Stereotactic System Leksell Vantage Stereotactic System	K261932 (2026)
Izi Medical Products, LLC Present in Europe in other categories	United States	Snap On Spherz Threaded Spherz Quick Spherz Navigated Brain Biopsy Cannula Disposable Passive Array - Blunt Probe DISP DYNAMIC REFERENCE FRAME	K143241 (2015)
KOH YOUNG TECHNOLOGY INC.	South Korea	Geniant Cranial	K253856 (2026)
Integra LifeSciences Corporation Present in Europe in other categories	United States	CRW® Integra® Integra® Luminant® CRW® Precision CRW™	K160811 (2016)
Exactech, Inc.	United States	EXACTECHGPS Truliant GPS	registered
ClearPoint Neuro, Inc. Present in Europe in other categories	United States	SmartFrame ClearPoint SmartFrame OR SmartFrame Array SMARTFrame Expanded Accessory Kit, 5 Fr ClearPoint Array	K243657 (2025)
Compass Intl., Inc.	United States	Compass International Compass COMPASS CYGNUS-PFS IGS System COMPASS Stereotactic Retractor System COMPASS Stereotactic System COMPASS CT Adaptation Stereotactic System	K964229 (1997)
Karl Storz GmbH & Co. KG Present in Europe in other categories	Germany	n.a. NAV1	registered
BRAIN NAVI BIOTECHNOLOGY CO., LTD. Present in Europe in other categories	Taiwan	Instrument Adaptor (5 mm) Instrument Registration Platform Cover Foot Controller Instrument Adaptor (2.2 mm) Instrument Holder S Nao Trac S	K242575 (2025)
Acclarent, Inc.	United States	TruDi Shaver Blade ACCLARENT PIVOT RELIEVA SPINPLUS NAV TruDi Probe TruDi NAV Suction TruDi NAVWIRE	K231862 (2023)
Globus Medical, Inc. Present in Europe in other categories	United States	EXCELSIUS GPS CREO	K182000 (2019)
Eemagine Medical Imaging Solutions GmbH Present in Europe in other categories	Germany	tracking tools stimguide visor2	K210109 (2022)
Localite GmbH	Germany	Localite TMS Navigator TS	K223577 (2023)
Synthes GmbH Present in Europe in other categories	United States	–	registered
Renishaw Mayfield Sarl Present in Europe in other categories	France	neuromate tool guide neuromate - Tool guide neuromate planning station hardware neuro\|mate® - Adaptation for Leksell Model G Elekta frame NMControl neuro\|mate® - Tool-holder locking screw	K181706 (2018)
Scopis GmbH	Germany	NOVA AR Registration pointer EM-D Instrument clamp forceps Patient tracker tabs (PU 100) Instrument port Instrument clamp 10-16 mm	K171661 (2017)
Smith & Nephew, Inc. Present in Europe in other categories	United States	PiGalileo TKR ACHIEVECAS PROFIX PIGALILEO	K083565 (2009)
Orthosoft, Inc. Present in Europe in other categories	Canada	Sesamoid NavitrackER Polaris	K071929 (2007)
Navinetics, Inc.	United States	NaviNetics Skull Anchor Key Kit NaviNetics MR Localizer Tubing Kit NaviNetics Ground Truth Fixture NaviNetics MR Localizer Kit NaviNetics Reusable Stereotactic Frame NaviNetics CT Localizer Kit	K231392 (2023)
Northern Digital Inc Present in Europe in other categories	Canada	NDI Passive Spheres NDI Passive Sphere Disposable Reflective Marker Spheres (DRMS) Disposable Reflective Marker Sphere (DRMS)	K033621 (2004)
Synaptive Medical, Inc. Present in Europe in other categories	Canada	BrightMatter Guide Software Modus Nav Software Pointer Tool (SS) BrightMatter Patient Reference BrightMatter Guide Calibration Block BrightMatter Pointer Sterilizable Storage Tray	K183325 (2019)
7D Surgical ULC Present in Europe in other categories	Canada	7D Surgical Cranial Sterilization Tray 7D Surgical Cranial Articulating Arm 7D Surgical Cranial Reference Frame 7D Surgical Cranial Pointer 7D Surgical FLASH EVD Non-Sterile Kit 7D Surgical Biopsy Arm	K242480 (2024)
Nexstim Oyj Present in Europe in other categories	Finland	Nexstim NBS System Nexstim Head Tracker Tape Nexstim NBS software Nexstim NBS software GER Nexstim NBS Orange Head Tracker Nexstim NBT software	registered
Inomed Medizintechnik GmbH Present in Europe in other categories	Germany	–	registered
SI-BONE, Inc. Present in Europe in other categories	United States	iFuse Navigation Tracking System	registered
Ad-Tech Medical Instrument Corporation Present in Europe in other categories	United States	Disposable Brain Biopsy Needle Kit	K112094 (2012)
Sinovation (Beijing) Medical Technology Co., Ltd	China	–	K220072 (2023)
Materialise NV Present in Europe in other categories	Belgium	ProPlan CMF	K111558 (2012)
PAJUNK GmbH Medizintechnologie	Germany	Disposable Pre-calibrated Biopsy Needle Disposable Biopsy Needle BRAINPRO BRAINPRO STRYKER	K230201 (2023)
Biomet Orthopedics, LLC Present in Europe in other categories	United States	MIH CURVED ACETABULAR IMPACTER HANDLE SELEX INSERTER HANDLE STRAIGHT EXACT BROACH HANDLE	registered
DEPUY ORTHOPAEDICS, INC. Present in Europe in other categories	United States	CUPTIMIZE SIGMA	K071334 (2007)
BIOSENSE WEBSTER (ISRAEL) LTD. Present in Europe in other categories	–	TruDi™ Navigation System Carto ENT	registered
Bayer Medical Care Inc. Present in Europe in other categories	United States	Ball Joint Guide Array (BJGA)-Navigation Set Ball Joint Guide Array (BJGA)-Guide Set	K250893 (2025)
Depuy, Inc.	United States	VELYS	registered
Gyrus Acmi, Inc. Present in Europe in other categories	United States	Diego	registered
IMAGE NAVIGATION LTD Present in Europe in other categories	Israel	IGI	registered
MEDTRONIC PS MEDICAL, INC.	United States	MR8 Stealth-Midas	registered
Zeta Surgical, Inc.	United States	Zeta Stylet — S Zeta Navigation System	K253663 (2026)
BIOMET SPINE LLC	–	Vital™	registered
Conmed Corporation Present in Europe in other categories	United States	CONMED	registered
Gsb LLC	United States	Microtable System	registered
MED-SURGICAL SERVICES, INC.	–	CBYON	registered
Magnus Medical, Inc.	United States	SAINT	registered
Monteris Medical,	United States	NeuroBlate NB3 FullFire™ 1.6 Laser Probe	K090240 (2009)
Phasor Health, LLC	United States	PHASOR	K250505 (2025)
RENISHAW P L C	–	neuroinspire	registered
SYRMA JOHARI MEDTECH LIMITED Present in Europe in other categories	India	Johari Digital Healthcare Ltd.	registered
Tonica Elektronik A/S Present in Europe in other categories	Denmark	MagPro	K221544 (2023)
inTRAvent Medical Partners, L.P.	United States	SOLOPASS 2.0 Patient Interface Device	K251317 (2025)
3C-Medical Intelligence GmbH Present in Europe in other categories	Germany	–	registered
3D Instrumentation Sdn Bhd	Malaysia	–	registered
7D Surgical, Inc. Present in Europe in other categories	Canada	–	K192945 (2019)
AD Supply Group Limited	United Kingdom	–	registered
ARCH Medical Solutions - Olive Branch	United States	–	registered
ARCH Medical Solutions - Seabrook	United States	–	registered
Alden Tool Company, Inc.	United States	–	registered
American Industrial Plastics, LLC	United States	–	registered
American Manufacturing and Engineering	United States	–	registered
Arch Medical Solutions	United States	–	registered
Arvato Netherlands B.V.	Netherlands	–	registered
Autocam Medical	United States	–	registered
Avalign Instruments & Implants	United States	–	registered
Axial Medical	United States	–	registered
B&G Manufacturing Company	United States	–	registered
BEMOTEC GmbH	Germany	–	registered
Baxter Healthcare Corp Present in Europe in other categories	United States	–	registered
Bayer Corp. Present in Europe in other categories	United States	–	registered
Biomerics	United States	–	registered
Biosense Webster, Inc. Present in Europe in other categories	United States	–	K192397 (2020)
Bradshaw Medical, Inc.	United States	–	registered
Brain Science Tools B.V.	Netherlands	–	registered
Branch Medical Group	United States	–	registered
CBR Enterprise Limited	Hong Kong SAR China	–	registered
CENOVA AB	Sweden	–	registered
Cardimed Asia Medikal Sanayi ve Ticaret Ltd Sti	Türkiye	–	registered
Classic Wire Cut Company, Inc.	United States	–	registered
ComDel Innovation, LLC	United States	–	registered
Confluent Medical Technologies, Inc.	United States	–	registered
Culver Tool & Engineering LLC dba SpiTrex CTE	United States	–	registered
DEPUY SPINE, LLC	United States	–	registered
DHF Praezisionsmechanik GmbH	Germany	–	registered
DePuy Synthes, Inc.	United States	–	registered
ELOS MEDTECH AB	Sweden	–	registered
EXO-S	Canada	–	registered
Elekta , Ltd. Present in Europe in other categories	United Kingdom	–	registered
Elite Medical, LLC	United States	–	registered
Elos Medtech Onyx	United States	–	registered
Engineered Medical Systems	United States	–	registered
Engineering CPR Inc.	Canada	–	registered
Ernst & Engbring Gmbh	Germany	–	registered
Euclide Care	France	–	registered
Eurofins inpac Medizintechnik GmbH	Germany	–	registered
FIVE STAR MANUFACTURING, INC.	United States	–	registered
FLEXBAR MACHINE CORP., dba Mediflex	United States	–	registered
FRIEDRICH DANIELS GMBH	Germany	–	registered

The 100 most active manufacturers are shown, out of 195.

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