ClearanceBrief
Panels › Neurology › Product code HAW · Class 2

Neurological Stereotaxic Instrument

Regulation 882.4560

5510(k)s in 12 months (426 all time)
8recalls 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
Decided510(k)Device and applicantCode
Oct 15, 2026K262214Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)
Guangzhou Aimooe Technology Co., Ltd., CN
HAW
Sep 10, 2026K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)
Koh Young Technology, Inc., KR
HAW
Aug 5, 2026K261932Leksell® Vantage Stereotactic System
Elekta Solutions AB, SE
HAW
May 1, 2026K253663Zeta Navigation System
Zeta Surgical, Inc.
HAW
Mar 26, 2026K253379Stealth AXiS Cranial clinical application
Medtronic Navigation, Inc.
HAW
Oct 21, 2025K231897NeuroAlign software
Medivis, Inc.
HAW
Sep 5, 2025K251317SOLOPASS 2.0 System
Intravent Medical Partners
HAW
Sep 4, 2025K250893Ball Joint Guide Array (66295)
Bayer Medical Care, Inc.
HAW
Jul 9, 2025K250505EZ-FIDUCIALS
Phasor Health, LLC
HAW
May 23, 2025K242575Stereotaxic Guiding Surgical Devices, NaoTrac S
Brain Navi Biotechnology Co., Ltd., TW
HAW
Feb 5, 2025K241327Navient Image Guide Navigation System (955-NC-NC), Cranial
Claronav, CA
HAW
Jan 28, 2025K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignm
Brainlab AG, DE
HAW
Jan 24, 2025K243657ClearPoint System (Software Version 3.0)
ClearPoint Neuro, Inc.
HAW
Jan 17, 2025K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)
Koh Young Technology, Inc., KR
HAW
Dec 27, 2024K242480FLASH EVD System (10-0002)
7D Surgical ULC, CA
HAW
Oct 4, 2024K242351Zeta Cranial Navigation System (ZNS131-US)
Zeta Surgical, Inc.
HAW
Apr 26, 2024K233703Bone Anchor (NGS-BA-01)
ClearPoint Neuro, Inc.
HAW
Jan 12, 2024K233155ClearPointer Optical Navigation Wand
ClearPoint Neuro, Inc.
HAW
Jan 12, 2024K233144ClearPoint Bone Screw Fiducials
ClearPoint Neuro, Inc.
HAW
Jan 12, 2024K233141SmartFrame OR
ClearPoint Neuro, Inc.
HAW
Jan 10, 2024K233903Zeta Cranial Navigation System (ZNS131-US)
Zeta Surgical, Inc.
HAW
Nov 27, 2023K233243ClearPoint System (Software Version 2.2)
ClearPoint Neuro, Inc.
HAW
Oct 19, 2023K231976StealthStation Cranial Software, v3.1.5 (9735585)
Medtronic Navigation, Inc.
HAW
Sep 15, 2023K232102ClearPoint Array System (Version 1.2)
ClearPoint Neuro, Inc.
HAW
Sep 9, 2023K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cr
Brainlab AG, DE
HAW
Sep 8, 2023K230661Zeta Cranial Navigation System
Zeta Surgical
HAW
Jul 21, 2023K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registra
Brainlab AG, DE
HAW
Jul 20, 2023K231103ROSA ONE Brain Application
Medtech S.A.S, FR
HAW
Jul 14, 2023K231392NaviNetics Reusable Stereotactic System (NN1000)
Navinetics, Inc.
HAW
Jun 18, 2023K220072Sinobot X1
Sinovation (Beijing) Medical Technology Co., Ltd., CN
HAW
Apr 19, 2023K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Plan
Brainlab AG, DE
HAW
Apr 17, 2023K223577Localite TMS Navigator TS
Localite GmbH, DE
HAW
Mar 17, 2023K221544MagVenture TMS Atlas Neuro Navigation System
Tonica Elektronik A/S, DK
HAW
Feb 22, 2023K230201Disposable Pre-calibrated Brain Biopsy Needle 2.0
PAJUNK GmbH Medizintechnologie, DE
HAW
Feb 16, 2023K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Na
Stryker Corporation, DE
HAW
Sep 16, 2022K222519ClearPoint System
ClearPoint Neuro, Inc.
HAW
Sep 8, 2022K213989Cranial EM System
Brainlab AG, DE
HAW
Aug 17, 2022K220897Disposable Brain Biopsy Needle 2.0
PAJUNK GmbH Medizintechnologie, DE
HAW
Jun 10, 2022K221087Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
Medtronic Navigation, Inc.
HAW
May 4, 2022K214065ROSA ONE Brain application
Medtech S.A.S, FR
HAW
Apr 12, 2022K214040ClearPoint Array System (version 1.1)
ClearPoint Neuro, Inc.
HAW
Apr 8, 2022K210109visor2 system
Eemagine Medical Imaging Solutions GmbH, DE
HAW
Dec 22, 2021K212397StealthStation S8 Cranial v2.0
Medtronic Navigation
HAW
Dec 3, 2021K201435Molecular Flow Simulations
Therataxis, LLC
HAW
Nov 12, 2021K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic
Brainlab AG, DE
HAW
Nov 3, 2021K211544Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
Brainlab AG, DE
HAW
Aug 27, 2021K203251SOLOPASS System
Intravent Medical Partners, LP
HAW
Jun 17, 2021K210700NaviNetics D1 Stereotactic System
Navinetics, Inc.
HAW
Jan 29, 2021K201752Disposable Pre-calibrated Suction
Brainlab AG, DE
HAW
Jan 22, 2021K202575ClearPoint Array System
ClearPoint Neuro, Inc.
HAW

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