meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
41
Latest Decision
2017-12-07

Clearances · page 17 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K170818 Craniomaxillofacial Distraction System (CMFD) Synthes USA Products, LLC PBJ Class II 2017-12-07
K172270 gammaCore-2 Eletrocore, LLC PKR Class II 2017-12-07
K172503 MR Conditional Cup Electrode, MR Conditional Webb Electrode Rhythmlink International, LLC GXY Class II 2017-12-01
K173233 ReliefBand 1.5 Reliefband Technologies GZJ Class II 2017-11-30
K162718 Foot Drop System (Model XFT-2001D) Shenzhen Xft Medical Limited GZI Class II 2017-11-30
K171803 HIVOX OTC Electrical Stimulator Hivox Biotek, Inc. NUH Class II 2017-11-29
K173006 Cefaly Dual Cefaly Technology PCC Class II 2017-11-28
K172603 Cerafix Dura Substitute Acera Surgical, Inc. GXQ Class II 2017-11-27
K173372 ExactechGPS Total Shoulder Application Blue Ortho OLO Class II 2017-11-24
K170959 DIXI Medical Microdeep Depth Electrode Dixi Medical GZL Class II 2017-11-24
K171884 I-Portal Portable Assessment System - Nystagmograph (I-PAS) Neuro Kinetics, Inc. GWN Class II 2017-11-22
K172462 OrthAlign Plus System Orthalign, Inc. OLO Class II 2017-11-22
K172451 Dr.MUSIC 3s Smartmedicaldevice Co., Ltd. NUH Class II 2017-11-17
K172849 Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray Intellijoint Surgical, Inc. OLO Class II 2017-11-16
DEN170018 NSS-2 System Innovative Health Solutions (Ihs), Inc. PZR Class II 2017-11-15
K172759 Smart External Drain (SED) System Aqueduct Critical Care, Inc. JXG Class II 2017-11-14
K172703 Disposable Snap Electrode Embla Systems GXY Class II 2017-11-13
K170725 Stryker Universal Mesh Stryker GWO Class II 2017-11-13
K171902 Nexstim Navigated Brain Therapy (NBT) System 2 Nexstim Plc OBP Class II 2017-11-10
K173271 Aesculap Slim Clip Applier Forceps Aesculap, Inc. HCI Class II 2017-11-10
K172006 Alivio Ventricular Catheter and Flusher System (Alivio System) Alcyone Lifesciences, Inc. JXG Class II 2017-11-09
K173192 CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit Codman & Shurtleff, Inc. GWM Class II 2017-11-08
K172711 Comet-PLUS Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) OLV Class II 2017-11-03
K172644 Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base Stimwave Technologies Incorporated GZB Class II 2017-11-03
K172301 Mako Partial Knee Application Mako Surgical Corp. OLO Class II 2017-11-02
K171026 Mytens Model: BW-TSX Bewell Connect Corp. NUH Class II 2017-11-01
K172268 iFuse Implant System- iFuse Navigation SI-BONE, Inc. OLO Class II 2017-10-31
K171525 Intellijoint HIP Generation 2B System Intellijoint Surgical, Inc. OLO Class II 2017-10-30
K162652 Smart Photon Micro-current Device, Model: EP-300 Li-Tek Electronic Technology Corporation NFO Class II 2017-10-25
K171647 BeneLife Premium Facial Treatment Pack, Model: QZ0701A Infinitus (China) Company , Ltd. NFO Class II 2017-10-23
K171257 ClearPoint System Mri Interventions, Inc. ORR Class II 2017-10-20
K172079 Avail Omron Healthcare, Inc. NUH Class II 2017-10-19
K172809 OTC Combo TENS/EMS System Well-Life Healthcare Limited NUH Class II 2017-10-18
K172034 Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap Stryker Corporation OLO Class II 2017-10-18
K172537 Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag Codman & Shurtleff, Inc. JXG Class II 2017-10-16
K171397 Sienna Ultimate Wireless Amplifier Ems Handels Gesellschaft M.B.H. GWL Class II 2017-10-06
K172667 MagVita TMS Therapy w/MagPro R20 Tonica Elektronik A/S OBP Class II 2017-10-05
K172022 CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) Codman & Shurtleff, Inc. JXG Class II 2017-10-03
K163326 SmartEP Intelligent Hearing Systems GWJ Class II 2017-09-29
K171661 Scopis Extended Instrument Set EM Scopis GmbH PGW Class II 2017-09-27
K171862 GALAXY G3 Mini Microcoil Delivery System Codman & Shurtleff, Inc. HCG Class II 2017-09-25
K163270 ISEN-Goggles with Data Viewer Isent Tech & Trading Company, Ltd. GWN Class II 2017-09-25
K171599 WiTouch Pro, WiTouch, Neubac Hollywog, LLC NUH Class II 2017-09-22
K171184 Persyst Mobile App Persyst Development Corporation OMB Class II 2017-09-21
K172219 Mako Total Knee Application Mako Surgical Corp. OLO Class II 2017-09-21
K163611 Pain Therapy Device Guangzhou Xinbo Electronic Co., Ltd. NUH Class II 2017-09-19
K171446 Cefaly Acute Cefaly Technology PCC Class II 2017-09-15
K172522 Mazor X Mazor Robotics , Ltd. OLO Class II 2017-09-15
K163666 neuro inspire Rensihaw Plc HAW Class II 2017-09-15
K171123 Leksell Vantage Stereotactic System Elekta Instrument AB HAW Class II 2017-09-15
K170937 VIPER PRIME navigated inserter Medos International SARL OLO Class II 2017-09-14
K163209 Fiagon Navigation System Fiagon GmbH HAW Class II 2017-09-14
DEN160018 reSet Pear Therapeutics, Inc. PWE Class II 2017-09-14
K171051 HORIZON Therapy System Magstim Company, Ltd. OBP Class II 2017-09-13
K170368 Sterile NS System Jeil Medical Corporation GWO Class II 2017-09-11
K172433 NICO BrainPath Nico Corporation GZT Class II 2017-09-07
K170442 Cranial Drill Bits and Accessories Ad-Tech Medical Instrument Corporation HBE Class II 2017-09-07
K163439 NaviENT Claronav, Inc. HAW Class II 2017-09-01
K163338 OMNIBotics Knee System Omnllife Science, Inc. OLO Class II 2017-09-01
K171507 CustomizedBone Service Fin-Ceramica Faenza S.P.A. GXN Class II 2017-09-01
K163448 GrindCare System Sunstar Suisse S.A. HCC Class II 2017-09-01
K170599 SureFlo EVD Catheter Arkis Biosciences, Inc. JXG Class II 2017-08-31
K170564 MyndMove System, MyndMove Functional Electrical Stimulator Myndtec, Inc. GZI Class II 2017-08-30
K171321 K2M Navigation Instruments K2m OLO Class II 2017-08-30
K171124 Nihon Kohden Wireless Input Unit WEE-1200 Nihon Kohden Corporation GWQ Class II 2017-08-25
K171459 Ceribell Instant EEG Headband Ceribell, Inc. GXY Class II 2017-08-21
K171143 Relievant Medsystems RF Generator Relievant Medsystems GXD Class II 2017-08-18
K170667 QEVO System with KINEVO 900 Carl Zeiss Meditec, AG GWG Class II 2017-08-18
K171651 EXCELSIUS GPS Globus Medical, Inc. OLO Class II 2017-08-16
K171332 Artemis Neuro Evacuation Device Penumbra, Inc. GWG Class II 2017-08-14
K163166 EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only Easywell Biomedicals, Inc. NUH Class II 2017-08-11
K170827 INTRACEPT Intraosseous Nerve Ablation System Relievant Medsystems GXI Class II 2017-08-09
K163446 AxoGen Nerve Cap Axogen Corporation JXI Class II 2017-08-08
K171366 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit Stimwave Technologies Inc., Dba Stimq, LLC GZF Class II 2017-08-04
K163393 Hi-Dow Wireless TENS/EMS System (Model HD-5N) Hi-Dow International, Inc. NUH Class II 2017-08-04
K171588 NuBODY Skin Toning Device Carol Cole Company Dba Nuface NFO Class II 2017-07-31
K171967 MagVita TMS Therapy System Tonica Elektronik A/S OBP Class II 2017-07-25
K170852 POD Packing Coil Penumbra, Inc. HCG Class II 2017-07-19
K171747 MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System Codman & Shurtleff, Inc. HCG Class II 2017-07-14
K162470 RT300 FES cycle ergometer Restorative Therapies, Inc. GZI Class II 2017-07-11
K171780 OrthAlign Plus System Orthalign, Inc. OLO Class II 2017-07-11
K171666 MPR2 logO DATALOGGER Raumedic AG GWM Class II 2017-07-06
K171669 g.Nautilus PRO G.Tec Medical Engineering GmbH GWL Class II 2017-07-05
K171267 NavLock Trackers Medtronic Navigation OLO Class II 2017-07-03
K171586 Smart External Drain (SED) System Aqueduct Critical Care, Inc. JXG Class II 2017-06-30
K163153 Livia Lifecare , Ltd. NUH Class II 2017-06-28
K170708 OWL RF INSULATED CANNULAE Diros Technology, Inc. GXI Class II 2017-06-27
K170902 Sprint System, Single Procedure Kit, Sprint System with Pad II, Single Procedure Kit, Sprint System, Multi-Procedure Kit, Sprint System, Sterile Components Kit, Sprint System, Stimulator Kit Spr Therapeutics, LLC NHI Class II 2017-06-26
K162797 SpringTMS Eneura, Inc. OKP Class II 2017-06-26
K170551 ImPACT Quick Test Impact Applications, Inc. POM Class II 2017-06-21
K171481 MagVita TMS Therapy System Tonica Elektronik A/S OBP Class II 2017-06-16
K162459 AccuPoint Electrode Microprobes For Life Science, Inc. Dba Neuron GZL Class II 2017-06-15
K170441 ElectroTek Mobilemedtek GWQ Class II 2017-06-05
K162681 Enobio Wireless EEG Neuroelectrics Barcelona S.L.U. GWQ Class II 2017-06-02
K163470 Galvanic Spa, Model: SKB-1405 Shenzhen Siken 3D Technology Development Co., Ltd. NFO Class II 2017-06-02
K170656 Reinforced Flexible Collagen Nerve Cuff Collagen Matrix, Inc. JXI Class II 2017-06-01
K171306 gammaCore-S Electrocore, LLC PKR Class II 2017-05-30
K170659 IQ Technologies Iq Technologies, Inc. NUH Class II 2017-05-26
K170242 MultiGen™ 2 RF Generator System Stryker Corporation GXD Class II 2017-05-25
K170891 Mako Partial Knee Application Mako Surgical Corp. OLO Class II 2017-05-24

6,130 clearances in the Neurology panel. Data: openFDA.