meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
48
Latest Decision
2019-03-08

Clearances · page 15 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K183177 Nitinol Thermocouple (TCN) Electrode Boston Scientific Corporation GXI Class II 2019-03-08
K182311 Cervella Innovative Neurological Devices, LLC QJQ Class II 2019-03-07
K181807 Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) Micro Therapeutics, Inc. d/b/a ev3 Neurovascular POL Class II 2019-03-06
K182267 PAT (Pain Alleviation Technologies) Marchan Medical, LLC NUH Class II 2019-02-27
K182976 SpringTMS Eneura®, Inc. OKP Class II 2019-02-25
K182542 The EPAD 2 System Safeop Surgical, Inc. GWF Class II 2019-02-22
K183241 BrainScope TBI (Model: Ahead 400) Brainscope Company, Inc. PIW Class II 2019-02-19
K182768 TMS-Cobot TS MV Axilum Robotics QFF Class II 2019-02-17
K183196 Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker Stryker Corporation OLO Class II 2019-02-14
K182417 ROSA ONE Brain Application Medtech S.A HAW Class II 2019-02-07
K182000 AQrate Robotic Assistance System Globus Medical, Inc. HAW Class II 2019-01-29
K183022 Solitaire 4 Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular POL Class II 2019-01-29
K182964 ROSA Knee System Orthosoft Inc (D/B/A Zimmer Cas) OLO Class II 2019-01-24
K183581 Codman Disposable Perforators Integra Lifesciences Corp. HBF Class II 2019-01-20
K182527 ELAN 4 Tools Aesculap, Inc. HBE Class II 2019-01-19
K182211 Aurora Surgiscope System Rebound Therapeutics Corporation GWG Class II 2019-01-18
K182111 DL Self-adhesive Electrode Shaoxing DL Healthcare Co., Ltd. GXY Class II 2019-01-17
K182227 Esprit Nova Neurozone Msh Incorporated OLZ Class II 2019-01-17
K183406 CereLink ICP Monitor, CereLink ICP Extension Cable Integra Lifesciences Corp. GWM Class II 2019-01-11
K182120 Maxpower Relief Omron Healthcare, Inc. NUH Class II 2019-01-10
K182721 Choice Spine Navigation System Choicespine, LP OLO Class II 2019-01-08
K182982 BridalVeil Navigated Instruments Astura Medical OLO Class II 2019-01-04
K183352 Optimus Neuro System Osteonic Co., Ltd. GWO Class II 2019-01-02
K181864 Polaris RF Ablation System Baylis Medical Company, Inc. GXD Class II 2019-01-02
K182025 ClearUP Sinus Pain Relief Tivic Health Systems, Inc. GZJ Class II 2019-01-02
DEN170091 EyeBOX Oculogica, Inc. QEA Class II 2018-12-28
K181861 Embrace Empatica S.r.l. POS Class II 2018-12-20
K183123 microTargeting Guideline 4000 5.0 System FHC, Inc. GZL Class II 2018-12-20
K181785 Modified BrainScope One Brainscope Company, Inc. PIW Class II 2018-12-19
K182424 NuFACE FIX Skin Toning Device Carol Cole Company Dba Nuface NFO Class II 2018-12-18
K173681 reSET-O Pear Therapeutics, Inc. PWE Class II 2018-12-10
K172897 Neck Care Therapy, Model: SYK 509B Shenzhen Osto Technology Co., Ltd. NUH Class II 2018-12-07
K180653 Spartan eCoil System Spartan Micro, Inc. HCG Class II 2018-12-04
K182757 Espire Elbow Pro, Espire Elbow Hybrid College Park Industries, Inc. GXY Class II 2018-11-29
K182181 Persyst 14 EEG Review and Analysis Software Persyst Development Corporation OMB Class II 2018-11-29
K182369 gammaCore Sapphire Electrocore, Inc. PKR Class II 2018-11-27
K172837 Low-frequency Multi-function physiotherapy instrument Shenzhen Osto Technology Co., Ltd. NUH Class II 2018-11-26
K182581 PlayMakar Sport Muscle Stimulator, Model PRO-500 Playmakar, Inc. NUH Class II 2018-11-21
K181731 MR Compatible Aspiration Kit Mri Interventions, Inc. GWG Class II 2018-11-20
K182265 CodMan Certas Plus Programmable Valve Integra Lifesciences Corp. JXG Class II 2018-11-20
K181709 Serenity Piezo Sensor, Serenity Thermocouple Sensor Neurotronics, Inc. OLV Class II 2018-11-16
K172907 ELAN 4 Air Motor System Aesculap, Inc. HBB Class II 2018-11-09
K181992 Heat Pain Pro Omron Healthcare, Inc. NUH Class II 2018-11-09
K181890 Brainlab Compatible K2M Navigation Instruments K2m OLO Class II 2018-11-09
K182565 AtriCure cryoICE cryoSPHERE cryoablation probe AtriCure, Inc. GXH Class II 2018-11-09
K180949 Steribite Rjr Surgical, Inc. HAE Class II 2018-11-08
K182425 Universal Mesh - Sterile Stryker Leibinger GmbH & Co KG GWO Class II 2018-11-06
K182077 Mazor X System (Mazor X Stealth Edition) Mazor Robotics , Ltd. OLO Class II 2018-11-02
K181195 ClearPoint System Mri Interventions, Inc. ORR Class II 2018-11-02
K182104 NavLock Trackers, Robotic Reference Frame Medtronic Navigation OLO Class II 2018-11-02
K182121 CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition Medtronic Sofamor Danek USA, Inc. OLO Class II 2018-11-02
K180247 DAEHAN Adhesive Surface Electrodes Daehan Medical Systems Co., Ltd. GXY Class II 2018-11-01
K182753 A6 OTC Pain Relief TENS Everyway Medical Instruments Co.,Ltd NUH Class II 2018-10-26
K182767 V2 OTC Pain Relief TENS Everyway Medical Instruments Co.,Ltd NUH Class II 2018-10-26
K181116 CONVIVO Carl Zeiss Meditec, AG GWG Class II 2018-10-25
K182706 External upper limb tremor stimulator Cala Health, Inc. QBC Class II 2018-10-25
K181186 Solitare Platinum Revascularization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular POL Class II 2018-10-25
K181902 Codman Certas Plus Electronic Tool Kit Integra Lifesciences Corp. JXG Class II 2018-10-25
K181596 Spine Wave Navigated Instruments Spine Wave, Inc. OLO Class II 2018-10-24
K181223 ImPACT Impact Applications, Inc. POM Class II 2018-10-20
K172709 ELAN 4 Electro Motor System Tools Aesculap, Inc. HBE Class II 2018-10-17
K180568 KidCap Eastern Cranial Affiliates, LLC MVA Class II 2018-10-16
K181848 ADAPT for Gamma3, Gamma3 Stryker GmbH OLO Class II 2018-10-12
K181539 OSSDSIGN Cranioplug Ossdsign AB GXR Class II 2018-10-12
K181008 NuFACE Trinity Carol Cole Company Dba Nuface NFO Class II 2018-10-11
K182112 Sense System with IBT Electrodes Infinite Biomedical Technologies, LLC GXY Class II 2018-10-05
K182436 POWEREASE System Medtronic Sofamor Danek USA, Inc. HBE Class II 2018-10-04
K181622 StrataMR guider tool Medtronic Neurosurgery JXG Class II 2018-10-01
K181771 RightEye Vision System Righteye, LLC GWN Class II 2018-09-28
K181707 Everyway Wireless TENS & EMS Unit Everyway Medical Instruments Co.,Ltd NUH Class II 2018-09-26
K182345 Spineology Navigation Instruments Spineology, Inc. OLO Class II 2018-09-21
K180981 Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit Stimwave Technologies Incorporated GZB Class II 2018-09-19
K181449 Ortoma Treatment Solution - OTS Ortoma AB OLO Class II 2018-09-19
K181102 ThermaCare Quick Therapy TENS Pfizer, Inc. NUH Class II 2018-09-15
K180369 Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) Relievant Medsystems GXI Class II 2018-09-14
K182214 DizzyDoctor System 1.0.0 Dizzydoctor Systems, LLC GWN Class II 2018-09-14
K172450 TENS device-HeadaTerm, eEspress Wat Medical Technology (Ningbo) Co., Ltd. PCC Class II 2018-09-13
K172834 Dual output digital therapy massager Shenzhen Osto Technology Co., Ltd. NUH Class II 2018-09-06
K181466 Cadwell Zenith System Cadwell Industries, Inc. GWQ Class II 2018-09-01
K180610 Geister retractor for neuro - and spine surgery Geister Medizin Technik GmbH GZT Class II 2018-08-29
K181060 Solitaire 2 and Solitaire Platinum Revascularization Device Medtronic Neurovascular POL Class II 2018-08-24
K180173 Freespira Palo Alto Health Sciences, Inc. HCC Class II 2018-08-23
DEN170078 Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System Brainways , Ltd. QCI Class II 2018-08-17
K180943 BioWaveGO Biowave Corporation GZJ Class II 2018-08-17
K173620 Mag Vita TMS Therapy System w/Theta Burst Stimulation Tonica Elektronik A/S OBP Class II 2018-08-14
K181849 iStim S2 OTC Pain Relief TENS Everyway Medical Instruments Co., Ldt. NUH Class II 2018-08-10
K181544 Anchor Bolt (as an accessory to Depth Electrodes) Ad-Tech Medical Instrument Corporation GZL Class II 2018-08-09
K181041 7D Surgical System Cranial Application 7D Surgical, Inc. HAW Class II 2018-08-08
K181234 Self-adhesive Electrode Dong Guan OU Kang Electronics Co., Ltd. GXY Class II 2018-08-07
K180907 HORIZON TMS Therapy System Magstim Company, Ltd. OBP Class II 2018-08-03
K181422 SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit Spr Therapeutics, Inc. NHI Class II 2018-07-31
K180064 OsteoFab Patient Specific Cranial Device Oxford Performance Materials, Inc. GXN Class II 2018-07-27
K181706 neuromate Gen III Renishaw Mayfield Sarl HAW Class II 2018-07-26
K181025 I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System Neuro Kinetics, Inc. GWN Class II 2018-07-24
K180854 Voyager Trajectory Array Guide (V-TAG) Voyager Therapeutics, Inc. HAW Class II 2018-07-23
K180948 TruDi NAV Suction Instruments Acclarent, Inc. PGW Class II 2018-07-20
K181382 GuardianTM Burr Hole Cover System St Jude Medical GXR Class II 2018-07-20
K173366 NicoletOne Natus Neurology Incorporated OLZ Class II 2018-07-20
K181062 Ultra Facial Toning System Micro Current Technology, Inc. NFO Class II 2018-07-18
K180269 Cadwell Apollo System Cadwell Industries, Inc. GWQ Class II 2018-07-17

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