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Neurology

6,099 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
NeuroStar Advanced Therapy (K201158)Neuronetics, Inc.2020-11-20
Codman Surgical Patties & Strips (K193346)Integra LifeSciences Corporation2020-11-20
Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) (K193576)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2020-11-20
Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 (K202317)Everyway Medical Instruments Co.,Ltd2020-11-13
TSolution One Total Knee Application (K203040)THINK Surgical, Inc.2020-11-13
Insight Infrared Video Goggles (K203082)Vestibular First2020-11-12
iFuse Implant System - iFuse Navigation (K203110)SI-BONE, Inc.2020-11-09
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits (K202274)Boston Scientific Neuromodulation2020-11-09
OGYILI TENS/NMES Stimulator (K201431)Gongguan Tutamen Metalwork Co., Ltd.2020-11-09
NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable (DEN200033)Nightware, Inc.2020-11-06
Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) (K201840)Rebound Therapeutics2020-11-04
Midas Rex Attachments and Dissecting Tools (K202552)Medtronic Powered Surgical Solutions (Mpss)2020-11-02
Longeviti ClearFit Cranial Implant (K202901)Longeviti Neuro Solutions, LLC2020-10-30
Sleepware G3 (K202142)Respironics, Inc.2020-10-29
NIM Vital, Nerve Integrity Monitor (K200759)Medtronic Xomed, Inc.2020-10-28
NextAR TKA Platform (K202152)Medacta International S.A.2020-10-27
Mazor X (K203005)Mazor Robotics , Ltd.2020-10-27
Li-Battery powered OTC TENS/EMS Combination Stimulator (K201335)Everyway Medical Instruments Co.,Ltd2020-10-24
Nerivio (K201824)Theranica Bio-Electronics, Ltd.2020-10-23
IonicRF Generator (K201610)ABBOTT MEDICAL2020-10-21
Transcutaneous Electronic Nerve Stimulator (K200237)Shenzhen Kentro Medical Electronics Co., Ltd.2020-10-19
Instrument Clamps Electromagnetic (K202609)Stryker Corporation2020-10-09
Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update (K192703)Brainlab AG2020-10-08
Tua Face Fitness / Tua Trend Face (K192077)Vupiesse S.R.L2020-09-30
Cefaly Dual (K201895)Cefaly Technology2020-09-29
Cadwell Apollo System (K201819)Cadwell Industries, Inc.2020-09-29
Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) (K191982)Shenzhen Kentro Medical Electronics Co., Ltd.2020-09-25
Nerve and Muscle Stimulator (K193276)Shenzhen Xft Medical Limited2020-09-23
DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (K192702)Synthes (USA) Products, LLC2020-09-18
Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set (K201661)Medos International SARL2020-09-16
VersaWrap Nerve Protector (K201631)Alafair Biosciences, Inc.2020-09-14
Navigation Module of the Momentum System (K200845)Ulrich Medical USA2020-09-10
Perseus (K192653)Orthokey Italia S.R.L.2020-09-09
EyeBOX (K201841)Oculogica, Inc.2020-09-06
MSLS6QF TENS/PMS Device (K193655)Self Doctor Care, LLC2020-09-04
7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array (K201966)7D Surgical, Inc.2020-09-03
ExactechGPS System (K193618)Blue Ortho2020-09-02
KLS Martin Individual Patient Solutions (IPS) Planning System (K201052)KLS-Martin L.P.2020-08-31
MindsEye Expandable Port (K202072)Minnetronix Neuro, Inc.2020-08-26
VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder (K200587)Orthosensor, Inc.2020-08-25
Brainsway Deep TMS System (K200957)Brainsway , Ltd.2020-08-21
Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit (K200848)Micron Medical Corporation2020-08-14
StimaWELL 120MTRS (K181645)Pierenkemper GmbH2020-08-13
SOMNOscreen plus (K201054)Somnomedics GmbH2020-08-12
Tyece OTC TENS Model (K200838)Tyece Limited2020-08-12
VisualEyes (K200534)Interacoustics A/S2020-08-12
TruDi Curette (K201174)Acclarent, Inc.2020-08-12
MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system (K193006)Tonica Elektronik A/S2020-08-09
K2M Navigation Instruments (K201006)K2m, Inc.2020-08-07
CarboClear Navigated Instruments (K201251)CarboFix Orthopedics , Ltd.2020-08-05
Navigation Enabled Intruments (K200791)Medos International SARL2020-07-31
BEAR and BEAR mini (K200803)Foreo, Inc.2020-07-31
Joimax Intracs System (K192663)Joimax GmbH2020-07-30
Ace Medical Surgical Instruments (K200387)Ace Medical2020-07-21
Wiggins Medical Surgical Instruments (K200383)Wiggins Medical2020-07-21
Nalu Neurostimulation SCS system (K201618)Boston Scientific Neuromodulation2020-07-15
Mako Total Knee Application (K193515)Mako Surgical Corp.2020-07-14
NextAR TKA Platform (K193559)Medacta Inernational SA2020-07-10
ExcelsiusGPS Cranial 1.0 Module (K200047)Globus Medical, Inc.2020-07-10
StimPlus Patch, StimPlus Patch, StimPlus Patch (K200561)Jkh Health Co., Ltd.2020-07-01
Electronic stimulator (K200354)Shenzhen Dongjilian Electronics Co., Ltd.2020-06-29
OMNIBotics Knee System (K200888)Corin, Ltd.2020-06-27
Streamline Navigated Instruments (K200095)Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.2020-06-26
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) (K200723)Medtronic Navigation, Inc.2020-06-26
Byteflies Kit (K192549)Byteflies NV2020-06-22
Harvey(R) Surgical Assistant (K200892)Orthalign, Inc.2020-06-18
TENS and Muscle Stimulator (K200727)Shenzhen Astec Technology Co., Ltd.2020-06-18
NavLock Trackers (K201327)Medtronic Navigation2020-06-18
REAL INTELLIGENCE CORI (CORI) (K201022)Blue Belt Technologies, Inc.2020-06-12
Electrical Stimulator System (K192201)Gymmax Technology Shenzen Co., Ltd.2020-06-12
TSolution® One Total Knee Application (K201255)THINK Surgical, Inc.2020-06-10
Naviswiss Hip Navigation System (K193094)Naviswiss AG2020-06-10
Flap Fixator, Burr Hole Cover (K192310)Ossaware Biotech Co., Ltd.2020-06-03
StealthStation Cranial Software v1.3.0 (K201175)Medtronic Navigation, Inc.2020-06-03
HIP7 (K193307)Brainlab AG2020-06-02
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) (K193438)Pro Med Instruments GmbH2020-06-02
BRAINSTREAM Disposable Deep Cup EEG Electrodes (K200540)Conmed Corporation2020-06-01
Stealthstation S8 Spine Software v1.3.0 (K201189)Medtronic Navigation, Inc.2020-05-29
ROSA ONE Brain application (K200511)Medtech S.A2020-05-29
Guardian Needle Electrode (K200984)Rhythmlink International, LLC2020-05-27
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level (K201118)Medtronic, Inc.2020-05-26
Natus NeuroWorks (K200878)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2020-05-18
Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) (K190118)Guangzhou Xinbo Electronic Co., Ltd.2020-05-13
Ventricular Catheter (K200950)Aesculap, Inc.2020-05-08
Mazor X (K200935)Mazor Robotics , Ltd.2020-05-08
LIVIA (K183110)Lifecare , Ltd.2020-05-04
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit (K200807)Irras USA, Inc.2020-04-29
MECTA Sigma (K192834)Mecta Corporation2020-04-26
i-ED COIL (K192068)Kaneka Pharma America, LLC2020-04-25
Maxxi Position Sensor (K191492)Neurovirtual USA, Inc.2020-04-24
GSI Audera Pro (K193033)Grason Stadler2020-04-24
Nurochek System (K200705)Cryptych Pty, Ltd.2020-04-23
Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) (K200162)Wuhan Greentek Pty , Ltd.2020-04-21
VERASENSE for Stryker Triathlon (K200665)Orthosensor, Inc.2020-04-12
OrthAlign Plus System (K200642)Orthalign, Inc.2020-04-10
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags (K200630)Medtronic, Inc.2020-04-09
Neural Navigator (K191422)Soterix Medical, Inc.2020-04-06
VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left (K193580)Orthosensor, Inc.2020-04-01
iCEWav Neuromonitoring Platform (K191868)Ice Neurosystems, Inc.2020-03-31
StimRouter Neuromodulation System (K200482)Bioness, Inc.2020-03-27
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