Review Panel
Neurology FDA 510(k) Clearances & Devices
- Cleared Devices
- 6,130
- Product Codes (page)
- 41
- Latest Decision
- 2019-10-29
Clearances · page 14 of 62
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K192173 | ROSA ONE Spine application | Medtech S.A | OLO | Class II | 2019-10-29 |
| K190556 | Zimmer Biomet Universal Navigation System | Zimmer Biomet Spine, Inc. | OLO | Class II | 2019-10-24 |
| K191979 | DORO QR3 XTom Headholder System | Pro Med Instruments GmbH | HBL | Class II | 2019-10-22 |
| K191943 | SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set | Medos International SARL | OLO | Class II | 2019-10-18 |
| K182073 | BcSs-PICNI-2000 Sensor | Braincare Desenvolvimento E Inovacao Tecnologica S.A. | GWM | Class II | 2019-10-17 |
| K191672 | NuFACE Mini Device | Carol Cole Company Dba Nuface | NFO | Class II | 2019-10-15 |
| K191684 | MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System | Integra LifeSciences Corporation | JXG | Class II | 2019-10-11 |
| K183674 | Electronic Pulse Stimulator | Shenzhen Leading Perfection Technology Co., Ltd. | NUH | Class II | 2019-10-11 |
| K192526 | Spine Wave Navigated Instruments | Spine Wave, Inc. | OLO | Class II | 2019-10-10 |
| K190523 | Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial | Ossdsign AB | PJN | Class II | 2019-10-10 |
| K182136 | Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) | Shenzhen Osto Technology Co., Ltd. | NUH | Class II | 2019-10-10 |
| K191369 | TSolution One Total Knee Application | THINK Surgical, Inc. | OLO | Class II | 2019-10-08 |
| K191854 | Premia Spine XL Instruments | Premia Spine, Ltd. | OLO | Class II | 2019-10-08 |
| K191507 | Intellijoint® Navigation System | Intellijoint Surgical, Inc. | OLO | Class II | 2019-10-01 |
| K181606 | Precision Spine Navigation Instrumentation | Precision Spine, Inc. | OLO | Class II | 2019-09-27 |
| K190536 | Mediracer NCS | Mediracer OY | JXE | Class II | 2019-09-25 |
| K191998 | Mako Total Hip Application, Mako Total Knee Application | Mako Surgical Corp. | OLO | Class II | 2019-09-24 |
| K182671 | Medi-Direct TENS Pen | Jkh USA, LLC | NUH | Class II | 2019-09-21 |
| K180523 | INTAI Surgery Navigation System | Intai Technology Corporation | OLO | Class II | 2019-09-20 |
| K191587 | L360 Thigh System | Bioness, Inc. | GZI | Class II | 2019-09-12 |
| K190815 | BrainScope TBI | Brainscope Company, Inc. | PIW | Class II | 2019-09-11 |
| K191301 | Ceribell Pocket EEG Device | Ceribell, Inc. | OMB | Class II | 2019-09-11 |
| K183215 | Focus TENS Therapy, Model PM710-M/-L | Omron Healthcare, Inc. | NUH | Class II | 2019-09-07 |
| K191435 | IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 | Nalu Medical, Inc. | GZF | Class II | 2019-09-06 |
| K190250 | Microscope Navigation | Brainlab AG | HAW | Class II | 2019-09-06 |
| K191179 | Myo Plus | Otto Bock Healthcare Products GmbH | GXY | Class II | 2019-09-04 |
| K191547 | ReliefBand | Reliefband Technologies, LLC | GZJ | Class II | 2019-08-30 |
| K190719 | Artemis Eye System | Penumbra, Inc. | GWG | Class II | 2019-08-30 |
| K183605 | Spine & Trauma Navigation | Brainlab AG | OLO | Class II | 2019-08-29 |
| K190269 | PureLift | Xtreem Pulse, LLC | NFO | Class II | 2019-08-28 |
| K191039 | Navigated T2 STRATOSPHERE Inserters and Navigated Templates | Medtronic Sofamor Danek USA, Inc. | OLO | Class II | 2019-08-26 |
| K190988 | GIM-STIM OTC TENS/EMS System | Gemore Technology Co, Ltd. | NUH | Class II | 2019-08-16 |
| K183203 | ELAN 4 Tools | Aesculap, Inc. | HBE | Class II | 2019-08-09 |
| K183276 | 7D Surgical System | 7D Surgical, Inc. | HAW | Class II | 2019-08-07 |
| K191012 | Navigated Pedicle Access Kit | Izi Medical Products, LLC | OLO | Class II | 2019-08-07 |
| K191225 | EEG Electrode Template | Rhythmlink International, LLC | GXY | Class II | 2019-08-05 |
| K182871 | Mini TENS Therapy Device | Shenzhen Jumper Medical Equipment Co., Ltd. | NUH | Class II | 2019-08-01 |
| K190887 | Leksell Vantage Stereotactic System | Elekta Instrument AB | HAW | Class II | 2019-08-01 |
| K190672 | StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 | Medtronic Navigation, Inc. | HAW | Class II | 2019-07-31 |
| K191183 | EyeBOX | Oculogica, Inc. | QEA | Class II | 2019-07-31 |
| K183288 | Transcutaneous Electrical Nerve Stimulator | Shenzhen Kentro Medical Electronics Co., Ltd. | NUH | Class II | 2019-07-30 |
| K182889 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | PPT | Class II | 2019-07-26 |
| K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | OLO | Class II | 2019-07-24 |
| K183545 | Anspach Helix Dissection Tools | The Anspach Effort, Inc. | HBE | Class II | 2019-07-19 |
| K190050 | Tech Dots - Adhesive and conductive gel | Spes Medica Srl | GYB | Class II | 2019-07-19 |
| K183325 | Modus Nav | Synaptive Medical, Inc. | HAW | Class II | 2019-07-14 |
| K190960 | Nalu Lead Blank (50cm) | Boston Scientific Neuromodulation | GZB | Class II | 2019-07-11 |
| K190229 | Stryker PEEK Customized Cranial Implant Kit | Stryker | GWO | Class II | 2019-07-11 |
| K190801 | PressOn Electrode Headset | Rhythmlink International, LLC | GXZ | Class II | 2019-07-10 |
| K190174 | Miethke Shunt System GAV 2.0 and SA 2.0 Valves | Aesculap, Inc. | JXG | Class II | 2019-07-05 |
| K190617 | Wrap accessory electrodes | Hi-Dow International, Inc. | GXY | Class II | 2019-07-02 |
| K191223 | NAVIO | Blue Belt Technologies, Inc. | OLO | Class II | 2019-06-28 |
| K190779 | Trevo XP ProVue Retriever | Stryker | POL | Class II | 2019-06-25 |
| K191151 | JKH Stimulator Plus | Jkh USA, LLC | NUH | Class II | 2019-06-21 |
| K182960 | ReliefBand | Reliefband Technologies, LLC | GZJ | Class II | 2019-06-21 |
| K191400 | Voyager Trajectory Array Guide (V-TAG) | Mri Interventions, Inc. | HAW | Class II | 2019-06-21 |
| K182742 | DB-CMF | Dimensional Bioceramics, LLC | GXP | Class II | 2019-06-20 |
| K190115 | MHD TENS | Minghuangda Electronic Co., Ltd. | NUH | Class II | 2019-06-19 |
| K191049 | Stryker MIS and Footed Attachments | Stryker Corporation | HBE | Class II | 2019-06-18 |
| K182524 | GALILEO Spine Alignment Monitoring System | MiRus, LLC | OLO | Class II | 2019-06-17 |
| K190700 | ELECTRODES PAD | Shenzhen Bestpad Technology Development Co., Ltd. | GXY | Class II | 2019-06-14 |
| K190172 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | Stryker | HBE | Class II | 2019-06-14 |
| K183513 | XenoSure Dura Biologic Patch | LeMaitre Vascular, Inc. | GXQ | Class II | 2019-06-13 |
| K183692 | Avid IF2 | Vision Quest Industries Inc./Dba VQ Orthocare | LIH | Class II | 2019-06-12 |
| K191285 | Spine & Trauma Navigation | Brainlab AG | OLO | Class II | 2019-06-11 |
| K183630 | SPINEART Navigation Instrument System | Spineart SA | OLO | Class II | 2019-06-10 |
| K190246 | NeuroShield | Monarch Bioimplants GmbH | JXI | Class II | 2019-05-31 |
| K191083 | COMPLETE CONTROL System Gen2 | Coapt, LLC | GXY | Class II | 2019-05-24 |
| K183644 | Stealth-Midas MR8 System | Medtronic Powered Surgical Solutions | OLO | Class II | 2019-05-22 |
| K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | Kelyniam Global, Inc. | GWO | Class II | 2019-05-21 |
| DEN180059 | Nerivio Migra | Theranica Bioelectronics , Ltd. | QGT | Class II | 2019-05-20 |
| K183381 | Navigation Enabled Instruments | Stryker | OLO | Class II | 2019-05-17 |
| K183515 | MR8 Drill System, Midas Rex MR8 ClearView Tools | Medtronic Powered Surgical Solutions | HBC | Class II | 2019-05-12 |
| K182180 | SPEAC System | Brain Sentinel, Inc. | POS | Class II | 2019-05-11 |
| K190504 | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator | Relievant Medsystems | GXI | Class II | 2019-05-03 |
| K190532 | TruDi NAV Wire | Acclarent, Inc. | PGW | Class II | 2019-05-03 |
| K182108 | Portable Electro-Stimulation Therapy Device | Guangzhou Longest Science & Technology Co., Ltd. | NUH | Class II | 2019-04-26 |
| DEN170064 | Comaneci, Comaneci Petit, Comaneci 17 | Rapid-Medical , Ltd. | PUU | Class II | 2019-04-24 |
| DEN180041 | Monarch eTNS System | Neurosigma, Inc. | QGL | Class II | 2019-04-19 |
| K183189 | Ultra OTC Facial Toning System | Micro Current Technology, Inc. | NFO | Class II | 2019-04-17 |
| K180757 | D-Clip; D-Clip Applier | Peter Lazic GmbH | HCH | Class II | 2019-04-12 |
| K190653 | ExcelsiusGPS | Globus Medical, Inc. | OLO | Class II | 2019-04-09 |
| K190416 | Dome Electrode | Coapt, LLC | GXY | Class II | 2019-04-04 |
| K183376 | HORIZON TMS Therapy System with Navigation | Magstim Company, Ltd. | OBP | Class II | 2019-04-03 |
| K180232 | DAEHAN Disposable CUP Electrodes | Daehan Medical Systems Co., Ltd. | GXY | Class II | 2019-04-03 |
| K182720 | Freedom Spinal Cord Stimulator (SCS) System | Stimwave Technologies Incorporated | GZB | Class II | 2019-03-29 |
| K183579 | Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits | Boston Scientific Neuromodulation | GZF | Class II | 2019-03-29 |
| DEN180024 | Leica FL400 | Leica Microsystems (Schweiz) AG | QFX | Class II | 2019-03-28 |
| K183154 | SM Electrodes | Hong Qiangxing (Shenzhen) Electronics Limited | GXY | Class II | 2019-03-26 |
| K182700 | Nexstim Navigated Brain Therapy (NBT) System 2 | Nexstim Plc | OBP | Class II | 2019-03-22 |
| K182848 | ROSA ONE Spine application | Medtech S.A | OLO | Class II | 2019-03-22 |
| K183047 | Nalu Neurostimulation System | Boston Scientific Neuromodulation | GZB | Class II | 2019-03-22 |
| K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation | OMC | Class II | 2019-03-19 |
| K182853 | HORIZON TMS Therapy System | Magstim Company, Ltd. | OBP | Class II | 2019-03-15 |
| K190347 | HIVOX OTC Electrical Stimulator | Hivox Biotek, Inc. | NUH | Class II | 2019-03-15 |
| K190285 | L300 Go System | Bioness, Inc. | GZI | Class II | 2019-03-14 |
| K182203 | JKH Stimulator Plus | Jkh USA, LLC | NUH | Class II | 2019-03-14 |
| K183437 | AirRay Subdural Cortical Electrodes | Cortec GmbH | GYC | Class II | 2019-03-12 |
| K183303 | Brainsway Deep TMS System | Brainsway , Ltd. | QCI | Class II | 2019-03-08 |
| K190256 | Rulo Radiofrequency Lesion Probe | Epimed International, Inc. | GXI | Class II | 2019-03-08 |
6,130 clearances in the Neurology panel. Data: openFDA.