Product code HAW— Neurology
STEALTHSTATION TREATMENT GUIDANCE PLATFORM
- Advisory panel
- Neurology
- Total cleared
- 423
Adverse events under product code HAW
product code HAW- Death
- 52
- Injury
- 1,083
- Malfunction
- 17,300
- Total
- 18,435
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code HAW
1–100 of 423- K253663 — Zeta Navigation System
- K253379 — Stealth AXiS Cranial clinical application
- K231897 — NeuroAlign software
- K251317 — SOLOPASS 2.0 System
- K250893 — Ball Joint Guide Array (66295)
- K250505 — EZ-FIDUCIALS
- K242575 — Stereotaxic Guiding Surgical Devices, NaoTrac S
- K241327 — Navient Image Guide Navigation System (955-NC-NC), Cranial
- K243698 — Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT
- K243657 — ClearPoint System (Software Version 3.0)
- K241333 — Geniant Cranial (Navigated Neurosurgical Positioning Robot)
- K242480 — FLASH EVD System (10-0002)
- K242351 — Zeta Cranial Navigation System (ZNS131-US)
- K233703 — Bone Anchor (NGS-BA-01)
- K233141 — SmartFrame OR
- K233144 — ClearPoint Bone Screw Fiducials
- K233155 — ClearPointer Optical Navigation Wand
- K233903 — Zeta Cranial Navigation System (ZNS131-US)
- K233243 — ClearPoint System (Software Version 2.2)
- K231976 — StealthStation Cranial Software, v3.1.5 (9735585)
- K232102 — ClearPoint Array System (Version 1.2)
- K223864 — Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
- K230661 — Zeta Cranial Navigation System
- K223288 — Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
- K231103 — ROSA ONE Brain Application
- K231392 — NaviNetics Reusable Stereotactic System (NN1000)
- K220072 — Sinobot X1
- K223552 — Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
- K223577 — Localite TMS Navigator TS
- K221544 — MagVenture TMS Atlas Neuro Navigation System
- K230201 — Disposable Pre-calibrated Brain Biopsy Needle 2.0
- K212194 — Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System
- K222519 — ClearPoint System
- K213989 — Cranial EM System
- K220897 — Disposable Brain Biopsy Needle 2.0
- K221087 — Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
- K214065 — ROSA ONE Brain application
- K214040 — ClearPoint Array System (version 1.1)
- K210109 — visor2 system
- K212397 — StealthStation S8 Cranial v2.0
- K201435 — Molecular Flow Simulations
- K210989 — Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System
- K211544 — Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
- K203251 — SOLOPASS System
- K210700 — NaviNetics D1 Stereotactic System
- K201752 — Disposable Pre-calibrated Suction
- K202575 — ClearPoint Array System
- K203639 — StealthStation Cranial Software v1.3.2
- K192703 — Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update
- K201175 — StealthStation Cranial Software v1.3.0
- K200511 — ROSA ONE Brain application
- K191422 — Neural Navigator
- K200079 — ClearPoint System and Accessories
- K192945 — 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
- K191597 — Stealth Autoguide System, Midas Rex Legend Depth Stop System
- K190250 — Microscope Navigation
- K183276 — 7D Surgical System
- K190887 — Leksell Vantage Stereotactic System
- K190672 — StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
- K183325 — Modus Nav
- K191400 — Voyager Trajectory Array Guide (V-TAG)
- K182417 — ROSA ONE Brain Application
- K182000 — AQrate Robotic Assistance System
- K181041 — 7D Surgical System Cranial Application
- K181706 — neuromate Gen III
- K180854 — Voyager Trajectory Array Guide (V-TAG)
- K180206 — neuromate Gen III
- K172444 — ROSA BRAIN (v3.0.0.5)
- K172820 — Microscope Navigation Software
- K163666 — neuro inspire
- K171123 — Leksell Vantage Stereotactic System
- K163209 — Fiagon Navigation System
- K163439 — NaviENT
- K162655 — StealthConnect Remote Viewing, Planning and Collaboration System
- K162309 — StealthStation S8 System Platforms and StealthStation Cranial Software
- K162929 — Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker
- K162604 — Cranial Reducing Tubes
- K160811 — CRW STEREOTACTIC SYSTEM
- K153660 — StealthStation System with Cranial Software
- K152764 — EXACTECH GPS
- K160523 — BrightMatter Guide with BrightMatter Pointer
- K151156 — Fiagon Navigation System
- K153281 — BrightMatter Guide with Surface Trace Registration
- K160434 — ClearPoint System
- K152558 — Leksell Stereotactic System, Injection/ Aspiration Needle Kit
- K151359 — ROSA Brain
- K143420 — SYMBIS Surgical System
- K142505 — ClearPoint System
- K150301 — NavSuite3 Kit
- K150216 — Synergy Cranial
- K143241 — MDT Navigable Brain Biopsy Cannula
- K142024 — BRIGHTMATTER NAVIGATION SYSTEM
- K141833 — STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION
- K142344 — DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System
- K141559 — V-GUIDE FOR VENTRICULOSTOMIES
- K140705 — NAVIGABLE BRAIN BIOPSY CANNULA SET
- K133444 — STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM
- K140868 — STRYKER KWIC NEEDLE
- K132755 — NEUROMATE FRAMELESS GEN II
- K132611 — MICROTABLE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.