FDA Registration
Active
🇩🇪 Germany
BRAINLAB SE
Reg #: 8043933
·
FEI: 3002619595
·
Expires 2026
Products
37
Proprietary Names
594
Establishment Types
2
Classifications
37
Registration Details
- Registration Name
- BRAINLAB SE
- Registration Number
- 8043933
- FEI Number
- 3002619595
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Olof-Palme-Strasse 9
- City
- Munich Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K190250
Owner / Operator
- Firm Name
- Brainlab SE
- Operator Number
- 9004547
- Address
- Olof-Palme-Strasse 9
- City
- Munich
- State
- Bavaria
- Postal Code
- 81829
- Country
- DE
US Agent
- Business Name
- BRAINLAB, INC.
- Contact Name
- Paul Neil
- Address
- 5 Westbrook Corporate Ctr Ste 1000
- City
- WESTCHESTER
- State
- IL
- ZIP
- 60154
- Country
- US
- [email protected]
- Phone
- 708 4091343
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2019-09-12 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2018-06-08 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2022-08-31 |
| Screwdriver, Skullplate | GXL | Class 1 | Neurology | No | 2023-05-02 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2012-05-15 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2012-05-15 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2020-08-27 |
| System, Radiation Therapy, Charged-Particle, Medical | LHN | Class 2 | Radiology | No | 2019-05-02 |
| Radiological Image Processing Software For Radiation Therapy | QKB | Class 2 | Radiology | No | 2024-01-10 |
| System, Planning, Radiation Therapy Treatment | MUJ | Class 2 | Radiology | No | 2024-01-10 |
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | Class 2 | Neurology | No | 2023-04-28 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2025-02-03 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2025-02-03 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2025-02-03 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2023-10-17 |
| Holder, Head, Neurosurgical (Skull Clamp) | HBL | Class 2 | Neurology | No | 2013-05-29 |
| Display, Cathode-Ray Tube, Medical | DXJ | Class 2 | Cardiovascular | No | 2021-04-21 |
| Headrest, Neurosurgical | HBM | Class 1 | Neurology | No | 2025-09-22 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2007-05-17 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2023-07-17 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2012-11-07 |
| Brain Stimulation Programming Planning Software. | QQC | Class 2 | Neurology | No | 2022-04-25 |
| System, X-Ray, Film Marking, Radiographic | JAC | Class 1 | Radiology | No | 2012-11-16 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2016-03-14 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2025-07-14 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2025-02-03 |
| Table, Surgical With Orthopedic Accessories, Ac-Powered | JEA | Class 1 | General, Plastic Surgery | No | 2019-06-14 |
| Table, Radiographic, Stationary Top | IXQ | Class 2 | Radiology | No | 2015-09-14 |
| Catheter, Ventricular | HCA | Class 2 | Neurology | No | 2014-03-07 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2016-07-14 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2018-12-05 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2023-12-18 |
| Phantom, Anthropomorphic, Radiographic | IXG | Class 1 | Radiology | No | 2007-04-23 |
| Orthopedic Augmented Reality | SBF | Class 2 | Neurology | No | 2025-05-19 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2025-02-04 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2025-02-04 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2019-12-03 |
Proprietary Names
Microscope Navigation
Microscope Tracking Array
Microscope Adapter For Tracking Array (ZEISS)
Microscope Adapter For Tracking Array (LEICA)
27 Touchdisplay Foreseeson
MDSC-2226, MDSC-2232, MDSC-2242, MDSC-2324, MDSC-2326, MDSC-8231, MDSC-8255, MDSC-8258, MDSC-8527NXF M2, MDSC-8532NXF M2
Barco Display
Alignment Software Spine
Navigation Software Spine & Trauma
Spine & Trauma Navigation
Alignment System Spine
Cirq Robotic Disposable Kinematic Unit
Cirq Robotic Tracking Array Spine 10
Alignment Guide Tube Spine 2.4/10
DRILL BIT 3.2 MM DEPTH CONTROL 60-100 MM
Alignment Guide Tube Spine 2.6/10
CIRQ ROBOTIC TRACKING ARRAY 10
Alignment Trocar Spine 3.2
DRILL BIT 4.5 MM DEPTH CONTROL 60-100 MM
Cirq Arm System
Kick 2 Navigation Station
Cirq Robotic Depth Tracking Array black
Cirq Robotic Depth Tracking Array beige
Buzz Navigation (Ceiling-Mounted)
Spine Navigation
Curve Navigation
Registration Fluoro 3D
Alignment Trocar Spine 2.4
Cirq Robotic Instrument Holder Spine
Curve Navigation 17700
Alignment Bone Anchor Cranial 2.1/3.8
DRILL BIT 4.5 MM DEPTH CONTROL 060 MM
Alignment Trocar Spine 2.6
Alignment Trocar Spine 6/10
Alignment Guide Tube Spine 3.2/10
Alignment Depth Control Spine
Automatic Registration
Skull Reference Screwdriver Blade
Hex Screwdriver Ball-End (2.5 mm)
Skull Reference Screwdriver Handle
DOUBLE OPEN-END WRENCH (10 X 14 MM)
Hex Screwdriver T-Handle (2.5 mm)
Elements Segmentation CMF
Elements Lead Localization
Elements Segmentation Basal Ganglia
Elements Segmentation Head & Neck
Elements Segmentation Thoracic & Spine
Elements Segmentation Spine
Elements SmartBrush
Elements Segmentation Cranial
Elements Trajectory Planning
Elements Segmentation Pelvic
Elements Anatomical Mapping
Elements Object Manipulation
Elements SmartBrush Angio
Elements SmartBrush Spine SRS
Elements Fibertracking RT
Elements Fibertracking
iPlan
iPlan CMF
Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
Cranial 4Pi Immobilization
CRANIAL 4PI HEADREST INLAY H&N 2PCS
CRANIAL 4PI STEREOTACTIC MASK (5PCS.)
CRANIAL 4PI HEADREST LOW-NECK
CRANIAL 4PI HEADREST INLAY OPENFACE 2PCS
CRANIAL 4PI HEADREST STANDARD
CRANIAL 4PI OPEN FACE MASK (5PCS.)
CRANIAL 4PI HEADREST INLAY STANDARD 2PCS
CRANIAL 4PI BASIC MASK (5 PCS.)
CRANIAL 4PI EXTENDED MASK (5 PCS.)
CRANIAL 4PI HEADREST INLAY OPENFACE
CRANIAL 4PI HEADREST INLAY H&N
Elements Image Fusion Angio
Brainlab Elements Image Fusion Angio
Image Fusion Angio
ARTPlan
ENT EM
Skull Reference Base EM
EM Registration Pointer
EM Instrument Tracker
Kick 2 Navigation Station EM
EM Pointer
EM Short Pointer
EM Patient Reference
Disposable Skull Reference Bone Fixation Screw 1.5 mm x 6 mm
Disposable Skull Reference Drill Bit 1.1 mm for Bone Fixation Screw
ARIETTA Precision
Drill Guide Depth Control (60-100 mm)
Drill Bit
Drill Guide Tube (3.2 mm)
Drill Guide Handle Compact
Drill Guide Array
Drill Guide Depth Control (0-60 mm)
Drill Guide Trocar Insert (2.6)
Drill Guide Trocar Insert (2)
Drill Guide Tube (2 mm)
DRILL BIT 2 MM DEPTH CONTROL 060 MM
Drill Guide Trocar Insert (2.4)
Drill Guide
Drill Guide Trocar Insert (4.5)
Drill Guide Tube (4.5 mm)
Drill Guide Tube (2.4 mm)
Sterilization Tray Drill Guide
Drill Guide Tube (2.6 mm)
Drill Guide Trocar Insert (3.2)
Drill Guide Handle
TraumaCAD
Cirq Robotic Alignment Module Spinal
Cirq
CIRQ Robotic Alignment Cranial and Spine System
Cirq Robotic Alignment System
Cirq Robotic Alignment Cranial And Spine
Mixed Reality Viewer
Viewer 5.4
Elements Viewer
Elements Viewer Smart Layout
Double Open-End Wrench (10 X 14 MM)
DISPOSABLE STERILE RADIOLUCENT SKULL PINS
ExacTrac Dynamic Surface
ExacTrac Dynamic 2
ExacTrac® X-Ray
Exactrac
Cranial Navigation
Navigation Software Cranial
Navigation Software Craniofacial
DRAPELINK REF ADAPTER AUTO-REG IMRI
Ultrasound Navigation
Buzz Navigation (Ceiling Mounted)
Automatic Registration iMRI
Cranial EM System
EM Stylet
AUTO-REG MATRIX IMRI
Nexxis OR
MobiCT-32
AIRO Mobile CT System
MRI LINE MARKER
Reinforcement-Arm
C-ARM ADAPTER GE OEC 3D RIGHT
INSTRUMENT ADAPTER CLAMP STARLINK SOFTGRIP SIZE XL
Mechatronic VarioGuide
Mechatronic Arm
Surgical Base System - SBS
CIRQ
Spine and Trauma 3D Navigation
Kick 2 EM Navigation Station
INSTRUMENT ADAPTER CLAMP STARLINK SIZE S
C-ARM REFERENCE UNIT RIGHT
CHISEL LONG FOR OPEN SURGERY
Drill Guide Depth Control
REFLECTIVE DISKS FLUORO KIT REV2-21 PCS
PATIENT REFERENCE ARRAY T-GEOMETRY X-PRESS
INSTRUMENT TRACKING ARRAY STARLINK SIZE M
Drill Guide Depth Control (200mm)
INSTRUMENT ADAPTER CLAMP STARLINK SIZE XL
Tissue Protection Sleeve Grip
PATIENT REFERENCE ARRAY Y-GEOMETRY X-PRESS
INSTRUMENT TRACKING ARRAY S&T (SIZE ML)
INSTRUMENT TRACKING ARRAY STARLINK SIZE XL
ADAPTER LONG FOR PATIENT REFERENCE CLAMP
HANDLE UNIVERSAL FOR OPEN SURGERY
INSTRUMENT ADAPTER STARLINK EXTENSION 50 MM
C-ARM ADAPTER SIEMENS CIOS SPIN RIGHT
INSTRUMENT TRACKING ARRAY S&T 3-MARKER
INSTRUMENT ADAPTER CLAMP STARLINK SOFTGRIP SIZE L
CHISEL SHORT FOR OPEN SURGERY
BONE FIXATOR 2-PIN X-PRESS
ADAPTER FOR SURGICAL MOTOR SYSTEM
INSTRUMENT ADAPTER CLAMP STARLINK SIZE M
AWL (4 MM) FOR OPEN SURGERY
DISP FIXATION PIN 4 x 125 MM (10 PCS)
C-ARM REFERENCE UNIT LEFT
Cirq Instrument Holder Module
AWL (3 MM) FOR OPEN SURGERY
C-ARM ADAPTER ZIEHM RFD 3D RIGHT
Drill Guide Compact Handle 4 Markers
INSTRUMENT TRACKING ARRAY STARLINK SIZE L
INSTRUMENT TRACKING ARRAY S&T (SIZE L)
RADIOLUCENT DRAPELINK INTERFACE FOR CALIBRATION PHANTOM INTRAOPERATIVE CT
C-ARM ADAPTER ZIEHM RFD 3D LEFT
CALIBRATION PHANTOM ICT
INSTRUMENT TRACKING ARRAY STARLINK SIZE ML
C-ARM ADAPTER GE OEC 3D LEFT
PROBE STRAIGHT (3.5 MM) FOR OPEN SURGERY
INSTRUMENT ADAPTER STARLINK ANGLED 45°
Cirq Instrument Holder Spinal Drilling
Drill Guide Depth Control Insertable
Guide Tube Pedicle Access Needle (1.8 mm)
INSTRUMENT TRACKING ARRAY S&T 4-MARKER
Drill Guide Handle 4-Marker
PROBE STRAIGHT (4.5 MM) FOR OPEN SURGERY
Instrument Calibration Matrix
PROBE CURVED (4.5 MM) FOR OPEN SURGERY
HANDLE GEARSHIFT FOR OPEN SURGERY
INSTRUMENT ADAPTER CLAMP STARLINK SIZE L
Disposable Trocar Insert Pedicle Access Needle (5 PCS)
C-ARM ADAPTER SIEMENS CIOS SPIN LEFT
ADHESIVE REFLECTIVE FLAT MARKERS (10PCS)
Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio
Buzz O.R Compute
Quentry Gateway
quentry.com; Quentry
Quentry Mobile Viewer; Quentry Mobile
Quentry Desktop
Quentry Basic Viewer
Patient Browser
Dicom Proxy
Buzz in-wall
Buzz on-wall
Buzz
Buzz Compact
Buzz Virtual App
Buzz Virtual
quentry.com
NOVALIS KNOWLEDGE BASE
NOVALIS KNOWLEDGE STUDY
Quip Eye
Wall Touch Screen
Brainlab Elements Fibertracking
Brainlab Elements BOLD MRI Mapping
Brainlab Elements 6
Brainlab Elements Contouring
Brainlab Elements Image Fusion
Patient Selection
Buzz 3rd Party: NDS Data Screen
WS-343DV-BEGNT
WS-343DV-BEG
BrainLAB Mask System
BrainLAB H & N Treatment System
Mask System
Head & Neck Treatment System
Patient Mask Set (5pcs)
ExacTrac Dynamic 1.1.2
RT Elements 4.5
Elements AI Tumor Segmentation RT
Elements SmartBrush [Angio, Spine] RT
(Elements) Retreatment Review
Elements Object Management RT
(Elements) RT Planning Platform
Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT
(Elements) Dose Review
(Elements) Multiple Brain Mets SRS
(Elements) Cranial SRS; (Elements) Spine SRS
(Elements) Cranial SRS w/ Cones
ExacTrac Dynamic
Guide 3
Brainlab Elements Guide XT
KingMark
VoyantMark
KingMark Calibration Device
VoyantMark Calibration Device
Calibration Device
VarioGuide Drill Kit
LoopX
CimMed
Brainlab Elements 7
Brainlab Elements BOLD MRI Mapping 1
Brainlab Elements Fibertracking 3
Brainlab Elements Image Fusion 5
Brainlab Elements Contouring 5
Brainlab Elements Image Fusion Angio 1
Disposable pre-calibrated suction
table, surgical with orthopedic accessories
Cirq Robotic Alignment Module
CIRQ Robotic Alignment Cranial And Spine System
Cirq Robotic Alignment Module Cranial
Cirq Robotic Tracking Array Cranial 7.5
DRILL BIT CRANIAL 3.4/3.8
Cirq Robotic Instrument Holder Cranial
DRILL DEPTH STOP CRANIAL 3.8
iBeam Couchtop
iBeam Evo Couchtop
Cirq Arm System 2
VARIOGUIDE HARDWARE (VERSION G)
RADIOLUCENT DRAPELINK ADAPTER FOR DORO SKULL CLAMP
Cranial Image Guided Surgery System
DISPOSABLE HEADBAND FOR PATIENT REFERENCE ARRAY (10 PCS)
RADIOLUCENT DRAPELINK INTERCONNECTOR
Gauge for Softouch Registration Pointer
DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE M) (3 PCS)
ULTRASOUND NAVIGATION ADAPTER (ALOKA C42K)
ULTRASOUND NAVIGATION ADAPTER GENERIC
HANDLE FOR MULTIPLE TIP POINTER
RADIOLUCENT DRAPELINK BASE SHORT
RADIOLUCENT DRAPELINK BASE LONG
Alignment Arm
DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE L) (3 PCS)
Skull Reference Base
ULTRASOUND NAVIGATION ADAPTER (ALOKA S31KP)
INSTRUMENT ADAPTER CLAMP STARLINK FOR RECTANGULAR INSTRUMENTS
ULTRASOUND NAVIGATION ADAPTER (BK X18L5S)
ULTRASOUND NAVIGATION ADAPTER (BK 8862/8863/N11C5S)
RADIOLUCENT DRAPELINK PATIENT REFERENCE ARRAY
DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE S) (3 PCS)
Skull Reference Array
V-INSET-IMRIS KIT
REGISTRATION MATRIX FOR IMRI HEAD HOLDER (NORAS)
VARIOGUIDE ARRAY
Pat. Ref. Attachment Arm for Skull Clamp
ULTRASOUND NAVIGATION TRACKING ARRAY
PATIENT REFERENCE ARRAY FOR DISPOSABLE HEADBAND
OR-Side-Rail Adapter for Supporting Arm CT
Pat. Ref. Array for Skull Clamp
RADIOLUCENT DRAPELINK ADAPTER FOR MAYFIELD SKULL CLAMP
Pat. Ref. T-Adapter for Skull Clamp
V-INSET GE HEADHOLDER KIT
Pat. Ref. Attachment for Skull Clamp
INSTRUMENT ADAPTER CLAMP STARLINK FOR CYLINDRICAL INSTRUMENTS
ULTRASOUND NAVIGATION ADAPTER (BK N13C5)
NDI Passive Spheres
Disp Fixation Pin 4 x 125 mm (10 pcs)
C-Arm Adapter GE OEC 3D Right
C-Arm Adapter Siemens Cios Spin Right
Radiolucent Drapelink Base Short
Cirq Robotics Tracking Array 10
Instrument Adapter Clamp Starlink Size S
Sterilization Tray Accessories Spine
Drill Guide Tube 2.6 mm X 200 mm
Disposable Trocar Insert Pedicle Access Needle
Hex Screwdriver T-Handle 2.5 mm
Bone Fixator "1-Pin", X-Press Size-S
Instrument Tracking Array Starlink Size ML
Sterilization Tray Accessories Spine MIS
Registration Matrix Minimally Invasive (Cranial and Spine)
C-Arm Adapter GE OEC 3D Left
Instrument Adapter Clamp Starlink for Cylindrical Instruments
Pedicle Access Needle Guide Tube 1.8 mm
Bone Fixator 2-Pin X-Press
Drill Bit 2.4 mm AO Shank
Radiolucent Drapelink Adapt Mayfield Clamp
Drill Bit 3.2 mm AO Shank
Trocar Insert 5mm
Sterilization Tray Registration 3D C-Arm
Sterilization Tray Cirq® Robotic Alignment Spine
Instrument Adapter Starlink Angled 45°
Drill Guide Depth Control (0 - 60 mm)
Hex Screwdriver 4 mm
Spine & Trauma Navigation Instruments
Drill Guide Tube 3 X 150 MM
Trocar Sharp Tip 3.2mm (200mm)
Instrument Tracking Array Starlink Size M
Drill Bit 4.5 mm AO Shank
DRAPELINK INTERFACE FOR ICT CALIBRATION PHANTOM
Bone Fixator "1-Pin", X-Press Size-M
Adhesive Reflective Flat Markers
Drill Bit 2.6 mm AO Shank Depth Control
Radiolucent Drapelink Adapt Doro Skull Clamp
Instrument Adapter Clamp Starlink Size XL
C-Arm Reference Unit Right
Hex Screwdriver Ball-End 2.5 mm
Instrument Adapter Clamp Starlink Softgrip Size XL
Drill Guide Tube 3.2mm X 200mm
Patient Reference Array Y-Geometry X-Press
Trocar Reduction Sleeve 2mm
Trocar Reduction Sleeve 2.8mm
Drill Guide Trocar Insert (2.6 mm)
Trocar Reduction Sleeve 3.2mm
Drill Guide Depth Control (60 - 100 mm)
Adapter for Surgical Motor System
Chisel Long for Open Surgery
Drill Bit 2.4 mm AO Shank Depth Control
Drill Guide Trocar Insert (3.2 mm)
Drill Bit 3.2 mm Depth Control (200 mm)
Patient Reference Array T-Geometry X-Press
Adapter Short for Patient Reference Clamp
Adapter Long for Patient Reference Clamp
Awl (4 mm) for Open Surgery
Drill Guide Tube 2.6mm X 150mm
Trocar Sharp Tip 2.4 mm
C-Arm Adapter Ziehm RFD 3D Right
Disposable Clip-on Remote Control
Spine Reference Clamp (Carbon)
PATIENT REFERENCE ROD-CLAMP SPINE & TRAUMA
Drill Guide Trocar Insert (4.5 mm)
Drill Guide Trocar Insert (2 mm)
Hex Screwdriver 2.5 mm
C-Arm Adapter Ziehm RFD 3D Left
Sterilization Tray Registration Universal Air
Radiolucent Drapelink Patient Reference Array
Drill Guide Tissue Protection Sleeve 10mm
Handheld Registration Device Fluoro 2D
Drill Guide Tube 4.5mm X 200mm
Drill Bit 3.2 mm AO Shank Depth Control
Instrument Adapter Clamp Starlink Size L
C-Arm Adapter Siemens Cios Spin Left
Probe Straight (3.5 mm) for Open Surgery
Sterilization Tray Instruments Trauma
Trocar Sharp Tip 2.6mm (200mm)
Sterilization Tray Accessories Spine & Trauma
Drill Bit 2 mm Depth Control 0-60 mm
Chisel Short for Open Surgery
Drill Bit 4.5 mm Depth Control 0-60 mm
Instrument Adapter Clamp Starlink for Rectangular Instruments
ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAY
Trocar Sharp Tip 2.6 mm
Registration Matrix CT Spine (Open Surgery)
Patient Reference Steel-Clamp Spine & Trauma Size S
Instr. Adapter Array (Starlink), Size XL
Instrument Adapter Clamp Starlink Softgrip Size L
Registration Matrix Small Incision (Spine)
Sterilization Tray Registration 2D C-Arm
Instr, Adapter Array (Starlink), Size L
Drill Guide Tube 2.4 X 150mm
Bone Fixator "1-Pin", X-Press Size-L
Drill Bit 3.2 mm Depth Control 60-100 mm
Radiolucent Drapelink Base Long
C-Arm Reference Unit Left
Instrument Adapter Starlink Extension 50 mm
Probe Curved (4.5 mm) for Open Surgery
Drill Bit 2.6 mm Depth Control (200 mm)
Drill Guide Trocar Insert (2.4 mm)
Drill Guide Trocar Tube 5mm X 180mm
Cirq Robotic Depth Tracking Array Black
Patient Reference Steel-Clamp Spine & Trauma Size L
PATIENT REFERENCE ARRAY SPINE & TRAUMA
Double Open-End Wrench 10 x 14 mm
Pointer Sharp Tip Extended
Sterilization Tray Instruments Spine
Drill Bit 2.6 mm AO Shank
Awl (3 mm) for Open Surgery
Sterilization Tray Drill Guides 200 mm Spine
Instrument Adapter Clamp Starlink Size M
Radiolucent Drapelink Interconnector
Drill Bit 4.5 mm Depth Control 60-100 mm
Sterilization Tray Cirq® Instrument Holder Spine
Instrument Tracking Array S&T (Size L)
Trocar Sharp Tip 3.2 mm
Drill Guide Tube 3.2mm X150mm
Probe Straight (4.5 mm)for Open Surgery
RT Elements 4
iPlan Flow
Integrated Conical Collimator and Interlock System (ICVI)
Alignment Guide Tube Cranial 4/7.5
Alignment Guide Tube Cranial 2.5/7.5
VARIOGUIDE ARRAY 4-MARKER
Alignment System Cranial
Cirq Alignment Software Cranial Biopsy
Alignment Software Cranial
DRILL BIT CRANIAL 2.4/4
VARIOGUIDE DISC SET CRANIAL DRILL KIT
Alignment Reduction Tube Cranial 2.5/4
DRILL BIT CRANIAL 2.1/4
VARIOGUIDE JOINT DISC
DRILL DEPTH STOP CRANIAL 2.5
VARIOGUIDE JOINT ARRAY HOLDER
Cirq Alignment Software Cranial sEEG
Varioguide Alignment Software Cranial
VARIOGUIDE DISC SET 1.8 MM TO 4 MM
DRILL BIT CRANIAL 2.1/2.5
DRILL BIT CRANIAL 2.4/2.5
DRILL DEPTH STOP CRANIAL 4
VARIOGUIDE DISC SET 4 MM TO 8 MM
VARIOGUIDE JOINT ARM KIT
Alignment Guide Tube Cranial 3.8/7.5
Brainlab Flexible Catheter
Cranial 4Pi
TraumaCad Neo
HEX SCREWDRIVER T-HANDLE 2.5 MM
HEX SCREWDRIVER BALL-END 2.5 MM
HEX SCREWDRIVER 4 MM
HEX SCREWDRIVER 2.5 MM
Frameless Radiosurgery Components
Frameless SRS MASK SET EXTENDED (5 PCS.)
Frameless SRS CARBON BASE
Frameless SRS MASK SET CRANIAL (5 PCS.)
Navigation Software Vascular PAD
Vascular Navigation PAD 2
Leksell Vantage Stereotactic System
Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X
EM Disposable Stylet
Brainlab Elements - Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
Disposable Loop-X Source Drape
Patient Scan Drape
Light Handle Cover
27 Display Drape
iCT Scan Drape
Disposable Drape for Cirq with Instrument Holder Module
Disposable Drape for Cirq® Robotics
Kick Monitor Drape
Disposable Drap for Ultrasound Registration Phantom
Disposable Monitor Drape for Kick
Disposable Touch Screen Drape
Loop-X Disposable Sterile Drape Set
Disposable Loop-X Detector Drape
Disposable Loop-X Drape Set
pro-cart 35E
DISPOSABLE REFLECTIVE MARKER SPHERE
Kick Navigation Station
Kick Upgrade Navigation Station
Navigation SW ENT EM
Curve Ceiling-Mounted
Kick EM Navigation Station
Curve Dual Display
Curve 1.1 Dual Navigation Station
Curve Single Display
Navigation SW CRANIAL EM
Kick 2 Navigation Station DPS
Registration Software Cranial
Microscope Navigation Software
Curve 1.2 Dual Navigation Station
Ultrasound Navigation Software (BK)
Buzz Navigation Ceiling Mounted
DISPOSABLE STYLET
Navigation SW Cranial
Navigation SW ENT
Ultrasound Registration Phantom
Disposable Stylet
ExacTrac Dynamic 2.2
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
Constancy Phantom NORMI
Spine Planning 2
Mixed Reality Spine Navigation 1.1
Mixed Reality Spine Navigation 1
Viewer (5.4)
Elements Image Fusion
Elements Cranial Distortion Correction
Elements Contrast Clearance Analysis
Image Fusion
Elements Spine Curvature Correction
Elements Virtual iMRI Cranial
Spine Planning
Spine & Trauma 3D Navigation
Elements Screw Planning Spine
Spine & Trauma Navigation System
Elements Spine Screw Planning
Navigation Software Spine& Trauma 3D
DRILL BIT 4.5 MM AO SHANK
DRILL BIT 3.2 MM AO SHANK DEPTH CONTROL
DRILL BIT 2.6 MM AO SHANK
DRILL BIT 3.2 MM AO SHANK
DRILL BIT 2.4 MM AO SHANK DEPTH CONTROL
DRILL BIT 2.6 MM DEPTH CONTROL (200 MM)
DRILL BIT 2.6 MM AO SHANK DEPTH CONTROL
DRILL BIT 3.2 MM DEPTH CONTROL (200 MM)
DRILL BIT 2.4 MM AO SHANK
Nexstim NBS 5
Sterilization Tray Cirq® Robotic Alignment sEEG
VarioGuide Disc Set 4mm to 8mm
Auto-Reg Matrix iMRI
Alignment Guide Tube Cranial 4.9 mm / 8 mm
VarioGuide Disc Set 1.8mm to 4mm
Alignment Reduction Tube Cranial 8 mm / 10 mm
Drill Depth Stop Cranial 4.9 mm
Automatic Registration iMRI 1.1
Drill Bit Cranial 3.4/3.8
Automatic Registration 2.5
Alignment Software Cranial with LITT 2.1
Drill Depth Stop Cranial 4
Cranial IGS System Automatic Registration iMRI 1
VarioGuide Joint Arm Kit
Sterilization Tray Cirq® Robotic Alignment LITT
Alignment Bone Anchor Cranial 2.1/3.8
Drapelink Ref Adapter Auto-Reg iMRI
Drill Bit Cranial 2.1/4
Drill Bit Cranial 2.1/2.5
VarioGuide Array 4-Marker
Drill Bit Cranial 2.4/ 4
Sterilization Tray VarioGuide® Alignment System
Cirq Alignment Software Cranial LITT
VarioGuide Alignment Software Cranial
Drill Depth Stop Cranial 2.5
VarioGuide Array Holder
Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm
Drill Depth Stop Cranial 3.8
Sterilization Tray Cirq® Robotic Alignment Biopsy
Drill Bit Cranial 4.5 mm /4.9 mm
Drill Bit Cranial 2.4/2.5
Cirq Robotic Tracking Array 10
Alignment System Cranial, with Alignment Software Cranial with LITT
VarioGuide Joint Disc
VarioGuide Disc Set Cranial Drill Kit
Automatic Registration 2.6
Automatic Registration 2.7
Disposable Pre-calibrated Brain Biopsy Needle 2
Magic Leap
STERILIZATION TRAY ACCESSORIES ENT/CMF, STERI TRAY ACCESSORIES ENT/CMF
STERILIZATION TRAY ACCESSORIES CRANIAL (2 OF 2), STERI TRAY ACCESSORIES CRANIAL (2 OF 2)
STERILIZATION TRAY VARIOGUIDE® ALIGNMENT SYSTEM, STERI TRAY VARIOGUIDE® ALIGNMENT SYSTEM
STERILIZATION TRAY INSTRUMENTS TRAUMA, STERI TRAY INSTRUMENTS TRAUMA
STERILIZATION TRAY REGISTRATION 2D C-ARM, STERI TRAY REGISTRATION 2D C-ARM
STERILIZATION TRAY CIRQ® INSTRUMENT HOLDER SPINE, STERI TRAY CIRQ® INSTRUMENT HOLDER SPINE
STERILIZATION TRAY REGISTRATION UNIVERSAL AIR, STERI TRAY REGISTRATION UNIVERSAL AIR
STERILIZATION TRAY ACCESSORIES CRANIAL (1 OF 2), STERI TRAY ACCESSORIES CRANIAL (1 OF 2)
STERILIZATION TRAY ACCESSORIES EM (1 OF 2), STERI TRAY ACCESSORIES EM (1 OF 2)
STERILIZATION TRAY REGISTRATION 3D C-ARM, STERI TRAY REGISTRATION 3D C-ARM
STERILIZATION TRAY INSTRUMENTS SPINE, STERI TRAY INSTRUMENTS SPINE
STERILIZATION TRAY DRILL GUIDES 200 MM SPINE, STERI TRAY DRILL GUIDES 200 MM SPINE
STERILIZATION TRAY ACCESSORIES EM (2 OF 2), STERI TRAY ACCESSORIES EM (2 OF 2)
STERILIZATION TRAY DRAPELINK CRANIAL, STERI TRAY DRAPELINK CRANIAL
STERILIZATION TRAY ACCESSORIES SPINE MIS, STERI TRAY ACCESSORIES SPINE MIS
STERILIZATION TRAY CIRQ® ROBOTIC ALIGNMENT SPINE, STERI TRAY CIRQ® ROBOTIC ALIGNMENT SPINE
STERILIZATION TRAY ACCESSORIES SPINE, STERI TRAY ACCESSORIES SPINE
Disposable Biopsy Needle
Mint Lesion
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device