meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
41
Latest Decision
2016-03-04

Clearances · page 20 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K152547 DNAP Electrode Ad-Tech Medical Instrument Corporation GZL Class II 2016-03-04
K160237 Cefaly Cefaly Technology PCC Class II 2016-03-04
K152558 Leksell Stereotactic System, Injection/ Aspiration Needle Kit Elekta Instrument AB HAW Class II 2016-03-02
K153237 OrthAlign Plus System Orthalign, Inc. OLO Class II 2016-03-01
K150468 Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs K2 Medical GmbH & Co. KG HAE Class II 2016-02-29
K160096 InZone Detachment System Stryker Neurovascular HCG Class II 2016-02-19
K152648 Ennova Self-adhesive Electrode Suzhou Ennova Electronics Technology Co.,Ltd GXY Class II 2016-02-18
K153247 Fusion Compact Navigation System Medtronic Navigation, Inc. PGW Class II 2016-02-18
K153647 TSolution One w/ACG+ Surgical System THINK Surgical, Inc. OLO Class II 2016-02-16
K150277 Pain Therapy System, Model PTS-II Counter Scientific Development (Gz), Ltd. NUH Class II 2016-02-12
K150826 Nutra Face Lift Model PE8050 Nutra Luxe MD, LLC NFO Class II 2016-02-10
K153203 Navigation Instruments Globus Medical, Inc. OLO Class II 2016-02-03
K152915 EYE-SYNC Syncthink, Inc. GWN Class II 2016-01-29
K151354 Cervello STIM Blackrock Neuromed GYC Class II 2016-01-27
K150498 Discovery 24 Brainmaster Technologies, Inc. GWQ Class II 2016-01-26
K152670 DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables Medos International SARL GWM Class II 2016-01-22
K152676 FD TENS 2090, FD TENS 2095 Fuji Dynamics , Ltd. GZJ Class II 2016-01-22
K153594 MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) MicroVention, Inc. HCG Class II 2016-01-22
K152374 LL TENS 160A, LL TENS 160B Fuji Dynamics , Ltd. NUH Class II 2016-01-13
K152684 Nerve Capping Device Polyganics Innovations BV JXI Class II 2016-01-13
K152954 Quell Neurometrix, Inc. NUH Class II 2016-01-05
K151511 ROSA Spine Medtech S.A OLO Class II 2016-01-04
K152112 VisualEyes Interacoustics A/S GWN Class II 2015-12-29
K151364 Intellijoint HIP(tm) System Intellijoint Surgical, Inc. OLO Class II 2015-12-28
K152128 2-in-1 Abdominal Muscle Training & Back Pain Relief System Tohkai Precision Electrical Manufactory (Shenzhen) Limited NUH Class II 2015-12-23
K151050 Pacifier Activated Lullaby (PAL®) Power Medical Devices, LLC HCC Class II 2015-12-22
K152852 ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) Bayer Healthcare, LLC NUH Class II 2015-12-22
K150898 LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm Moller Medical GmbH JXG Class II 2015-12-18
K151359 ROSA Brain Medtech S.A HAW Class II 2015-12-18
K151279 Counter OTC TENS Device, Model CSD-737Z Counter Scientific Development (Gz), Ltd. NUH Class II 2015-12-16
K143711 Reaxon Plus Medovent GmbH JXI Class II 2015-12-02
K150077 SonicLift Pretika Corporation NFO Class II 2015-11-25
K151034 PainKARE Triowave Technologies NUH Class II 2015-11-21
K151692 BioArchitects Patient Specific Cranial/Craniofacial Plate Bioarchitects USA, LLC GXN Class II 2015-11-20
K150825 Collagen Dural Regeneration Matrix Collagen Matrix, Inc. GXQ Class II 2015-11-20
K152041 Renaissance X System Mazor Robotics , Ltd. OLO Class II 2015-11-17
K151504 ICS Impulse Gn Otometrics GWN Class II 2015-11-16
K150298 Entropy Module, E-ENTROPY-01 Ge Healthcare Filand OY OLW Class II 2015-11-12
K151382 Patient Contoured Implant-PEEK (PCI-PEEK) KLS Martin L.P. GXN Class II 2015-11-09
K150386 Tyece OTC TENS Device Tyece , Ltd. NUH Class II 2015-11-05
K150688 IdentEvent Optima Neuroscience, Inc. OMB Class II 2015-11-05
K152040 X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) Advanced Brain Monitoring, Inc. OMC Class II 2015-10-30
K143420 SYMBIS Surgical System Imris, Inc. HAW Class II 2015-10-30
K152481 DURAFORM Dural Graft Implant Codman & Shurtleff, Inc. GXQ Class II 2015-10-30
K152152 Codman Certas Plus Programmable Valve Medos International SARL JXG Class II 2015-10-27
K151600 R-40 EEG Amplifier Lifelines , Ltd. GWL Class II 2015-10-23
K143670 ICS CHARTR EP 200 WITH VEMP Gn Otometrics A/S GWJ Class II 2015-10-23
K150741 TSolution One w/ACG surgical System THINK Surgical, Inc. OJP Class II 2015-10-22
K142505 ClearPoint System Mri Interventions, Inc. HAW Class II 2015-10-21
K150308 Palm TENS Heat IN A Click, LLC NUH Class II 2015-10-20
K152574 Navio Blue Belt Technologies, Inc. OLO Class II 2015-10-20
K150804 QBioScan Medeia, Inc. GZO Class II 2015-10-19
K151479 EV-820 OTC Pain Relief TENS Everyway Medical Instruments Co.,Ltd NUH Class II 2015-10-16
K151693 Dr-Ho's Foot Pad Electrode Drtv Asia, Ltd. GXY Class II 2015-10-09
K151576 Neon EEG Incereb, Ltd. GXY Class II 2015-09-29
K152437 BiowaveHOME Neuromodulation Pain Therapy Device Biowave Corporation GZJ Class II 2015-09-25
K152216 SudoC Ld Technology, LLC GZO Class II 2015-09-24
K151979 STARband, STARlight Orthomerica Products, Inc. OAN Class II 2015-09-18
K142530 Partial Knee Application (PKA) Mako Surgical Corporation OLO Class II 2015-09-16
K143507 NFANT Feeding Solution Nfant Labs, LLC HCC Class II 2015-09-09
K143597 Navigated XIA 4.5 Polyaxial Screwdriver Stryker Corporate OLO Class II 2015-09-04
K143661 DirectInject Stryker GXP Class II 2015-09-02
K150154 ANAM Test System: Military Battery Vista Lifesciences, Inc. PKQ Class II 2015-08-28
K150771 RxG Distraction System KLS Martin L.P. PBJ Class II 2015-08-27
K152076 PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority Stryker GWO Class II 2015-08-26
K150971 Zekang Self-adhesive Electrode Jiangsu Zekang Medical Technology Co., Ltd. GXY Class II 2015-08-25
K143487 Lifelines iEEG Kvikna Ehf OLT Class II 2015-08-21
K150220 STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast Eb Neuro S.P.A. GWF Class II 2015-08-19
K150043 Transcutaneous Electrical Nerve Stimulators (TENS) Andon Health Co, Ltd. NUH Class II 2015-08-14
K143233 Mitsar-EEG Mitsar Co., Ltd. GWQ Class II 2015-08-13
K151929 PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE Persyst Development Corporation OMB Class II 2015-08-12
K143752 Total Knee Application (TKA) Mako Surgical Corp. OLO Class II 2015-08-06
K150641 MagVita TMS Therapy System Tonica Elektronik A/S OBP Class II 2015-07-31
K150371 Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH Diros Technology, Inc. GXI Class II 2015-07-30
K151033 Philips Self-Adhesive Electrodes Philips Consumer Lifestyle GXY Class II 2015-07-28
K151447 Axium Detachable Coil System Micro Therapeutics, Inc. d/b/a ev3 Neurovascular HCG Class II 2015-07-28
K150924 A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device Anchor Innovation Medical (A.I.M.) GZB Class II 2015-07-27
K151760 Barricade Embolization Coil System Blockade Medical HCG Class II 2015-07-27
K143268 TENS AND POWERED MUSCLE STIMULATOR Shenzhen As-Tec Technology Co., Ltd. NUH Class II 2015-07-21
K151035 PulseRelief Philips Consumer Lifestyle NUH Class II 2015-07-21
K151572 Penumbra Smart Coil Penumbra, Inc. HCG Class II 2015-07-10
K143607 I-Portal NOTC, VNG and VOG Neuro Kinetics, Inc. GWN Class II 2015-07-08
K150301 NavSuite3 Kit Stryker Leibinger GmbH & Co. KG - Navigation HAW Class II 2015-07-08
K151536 SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm Mri Interventions, Inc. HBG Class II 2015-07-08
K150995 Electronic Pulse Stimulator Shenzhen Jingkehui Electronic Co.., Ltd. NUH Class II 2015-07-06
K151147 STARband, STARlight Orthomerica Products, Inc. OAN Class II 2015-07-01
K150518 Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm Dupaco, Inc. JXL Class II 2015-06-29
K151387 Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade Stryker HBW Class II 2015-06-24
K142834 DiscoverEEG System, Model DE-401 Neurowave Systems, Inc. OLT Class II 2015-06-23
K133995 NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE Neurosoft , Ltd. OLT Class II 2015-06-19
K150231 Navigated Disc Prep Instruments and CAPSTONE Trials Medtronic Sofamor Danek USA, Inc. OLO Class II 2015-06-16
K150378 NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook Nico Corporation GZT Class II 2015-06-12
K150319 MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS Codman & Shurtleff, Inc. HCG Class II 2015-06-12
K150216 Synergy Cranial Medtronic Navigation, Inc. HAW Class II 2015-06-11
K150517 Freedom Spinal Cord Stimulator System Stimwave Technologies Incorporated GZB Class II 2015-06-05
DEN130033 COGNIVUE Cerebral Assessment Systems, Inc. PKQ Class II 2015-06-05
K142159 DISPOSABLE PRE-GELLED SURFACE ELECTRODE Rochester Electro Medical, Inc. GXY Class II 2015-06-03
K142794 Everyway Facial MENS Everyway Medical Instruments Co.,Ltd NFO Class II 2015-06-02
K143430 SmartTENS Easy Med Instrument Co., Ltd. NUH Class II 2015-05-29
K143198 Synapse Transcutaneous Electrical Stimulation Device Synapse Electroceutical Limited GZJ Class II 2015-05-27

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