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Neurology

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

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RecordFirmDate
7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key (K210457)7D Surgical, Inc.2021-06-21
Transcutaneous Electrical Nerve Stimulator (K202893)Wuxi Jiajian Medical Instrument Co., Ltd.2021-06-18
NaviNetics D1 Stereotactic System (K210700)Navinetics, Inc.2021-06-17
Migraine Tens Digital Pain Reliever (K210364)Shenzhen Dongdixin Technology Co., Ltd.2021-06-17
EnsoSleep (K210034)Ensodata, Inc.2021-06-16
Axon Therapy (K210021)Neuralace Medical, Inc.2021-06-11
Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H (K210756)Shenzhen Osto Technology Company Limited2021-06-11
Navigated Anterolateral Disc Prep Instruments (K211441)Medtronic Sofamor Danek USA, Inc.2021-06-09
SnugKap (K193383)Headstart, Ltd.2021-06-07
Perfect EMS (K200694)Tenscare, Ltd.2021-06-04
ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium (K201309)Mecta Corporation2021-06-04
Cognoa ASD Diagnosis Aid (DEN200069)Cognoa, Inc.2021-06-02
Well-Life Garment Electrodes (GM Series) (K200942)Well-Life Healthcare Limited2021-06-01
MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems (K211344)Medos International SARL2021-05-28
Neuro-IOM system with Neuro-IOM.NET software (K190703)Neurosoft , Ltd.2021-05-22
Quick-20m (K203331)Cgx, LLC2021-05-20
CUVIS-spine (K201569)Curexo, Inc.2021-05-19
TENS & EMS Device (K202866)Shenzhen Jian Feng Electronic Technology Co., Ltd.2021-05-19
NextAR RSA Platform (K210153)Medacta International S.A.2021-05-12
Rebellion, Phantom Multi-Bite Kerrison Rongeur (K200768)Morpheus AG2021-05-04
CereLink ICP Monitor (K210993)Integra Lifesciences Production Corporation2021-04-30
Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device (K191951)Avazzia, Inc.2021-04-27
STARband, STARlight, St. Louis Band (K203098)Orthomerica Products, Inc.2021-04-27
Neurolutions Upper Extremity Rehabilitation System (DEN200046)Neurolutions, Inc.2021-04-23
Brainsway Deep TMS System (K203735)Brainsway , Ltd.2021-04-23
Knee+ (K202750)Pixee Medical2021-04-21
ROSA Partial Knee System (K210121)Orthosoft D/B/A Zimmer Cas2021-04-19
Brainsway Deep (DTMS) System (K203616)Brainsway , Ltd.2021-04-16
OMNIVision system (K203751)Corin USA2021-04-12
Velocity Alpha Highspeed Surgical Drill System (K191479)Adeor Medical AG2021-04-11
hekaDrill (K193630)Zethon, Ltd.2021-04-09
DeGen Navigated Instrumentation (K203816)Degen Medical2021-04-02
ClearPath Disposable Introducer (K210251)Clearmind Biomedical2021-04-02
TSolution One Total Knee Application (K210668)THINK Surgical, Inc.2021-04-01
Longeviti PMMA Static Cranial Implant (K210616)Longeviti Neuro Solutions, LLC2021-03-31
DORO QR3 Headrest System (Aluminum) (K203505)Pro Med Instruments GmbH2021-03-29
REMI (K203827)Epitel, Inc.2021-03-29
ETD4000 (K202725)Therasigma, LLC2021-03-26
i-ED COIL System (K210638)Kaneka Medical America, LLC2021-03-26
Portable Neuromodulation Stimulator (PoNS) (DEN200050)Helius Medical, Inc.2021-03-26
MyCRO Band (K201426)Otto Bock Healthcare LP2021-03-26
Low-frequency Multi-function physiotherapy instrument (K200177)Shenzhen Kentro Medical Electronics Co., Ltd.2021-03-25
ANAM Test System (K201376)Vista Lifesciences, Inc.2021-03-25
Nalu Neurostimulation System (K203547)Boston Scientific Neuromodulation2021-03-25
TrueRelief Device (K202186)Truerelief2021-03-23
Navigated Spine Instruments (K203205)Stryker Spine2021-03-23
7D Surgical System - Drill Guide (K210555)7D Surgical, Inc.2021-03-23
SPINEART Navigation Instrument System (K210472)Spineart2021-03-19
Automatic Registration (K203679)Brainlab AG2021-03-18
Clarus Peel-Away Introducer Sheath (K200925)Clarus Medical, LLC2021-03-18
HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 (K203574)Hivox Biotek, Inc.2021-03-10
iCE-SG Subcutaneous Electrode Arrays (K201678)Ice Neurosystems, Inc.2021-03-08
NeuroCap (Model DEC22) (K202913)Memory MD, Inc.2021-03-05
Solitaire X Revascularization Device (K203358)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2021-03-01
Q-Collar (DEN200017)Q30 Sports Science, LLC2021-02-26
Erisma LP Navigated Instruments (K202956)Clariance, Sas2021-02-26
Trinity ELE Plus and Trinity ELE Plus Pro (K201906)Carol Cole Company Dba Nuface2021-02-24
Practical Navigation Surgical Guidance System (PNSGS) (K202184)Practical Navigation, LLC2021-02-24
BioWaveGO RX (K210202)Biowave Corporation2021-02-24
NuFACE Mini Plus (K201680)Carole Cole Company2021-02-19
Relivion (K203419)Neurolief , Ltd.2021-02-16
gammaCore Sapphire (K203546)Electrocore, Inc.2021-02-12
Digital NeuroPort Biopotential Signal Processing System (K202174)Blackrock Microsystems2021-02-10
MR Conditional Sticky Pad Electrode (K203079)Rhythmlink International, LLC2021-02-09
Stryker PEEK Customized Cranial Implant Kit (K203055)Stryker2021-02-09
SPEAC System (K200276)Brain Sentinel, Inc.2021-02-06
RESPONSE Navigation Instruments (K203573)OrthoPediatrics Corp.2021-02-04
Jiajian Self-Adhesive Electrode (K192568)Wuxi Jiajian Medical Instrument Co., Ltd.2021-02-03
Disposable Pre-calibrated Suction (K201752)Brainlab AG2021-01-29
HipXpert 3D Display and Anchoring Application (K200384)Surgical Planning Associates, Inc.2021-01-28
SPRINT PNS System (K202660)Spr Therapeutics, Inc.2021-01-22
Nerivio, FGD000075-4.7 (K203181)Theranica Bioelectronics , Ltd.2021-01-22
ClearPoint Array System (K202575)ClearPoint Neuro, Inc.2021-01-22
NuFace Trinity Plus Device (K201782)Carol Cole Company Dba Nuface2021-01-22
VELYS™ Robotic-Assisted Solution (K202769)Depuy Ireland UC2021-01-14
Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) (K202694)Vycor Medical, Inc.2021-01-14
StealthStation Cranial Software v1.3.2 (K203639)Medtronic Navigation, Inc.2021-01-13
ChoiceSpine Navigation System (K203561)Choice Spine, LLC2021-01-04
Sparrow Therapy System (K201873)Spark Biomedical, Inc.2021-01-02
NeuroAmp II, NeuroAmp II.5s (K193159)Corscience GmbH & Co. KG2020-12-30
Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever (K203219)Stryker Neurovascular2020-12-29
8-CH Electroencephalography Amplifier (K201747)Hipposcreen Neurotech Corp.2020-12-27
ImPACT Version 4 (K202485)Impact Applications, Inc.2020-12-25
AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) (K200697)AtriCure, Inc.2020-12-23
Scrambler Therapy Technology (Model ST-5A) (K201458)Delta International Services & Logistics S.R.L2020-12-23
CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System (K202320)Brainlab AG2020-12-23
Everyway Analog OTC TENS, model N103A/N302 (K202849)Everyway Medical Instruments Co.,Ltd2020-12-22
COOLIEF Cooled Radiofrequency Kit Advanced (K203066)Avanos Medical, Inc.2020-12-22
actiTENS (K202159)Sublimed2020-12-22
EZTrack (K201910)Neurologic, LLC2020-12-22
ADAPT for Gamma3 (K202749)Stryker GmbH2020-12-18
Longeviti ClearFit Cranial Implant (K203349)Longeviti Neuro Solutions, LLC2020-12-16
Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration (K200376)Navbit Pty, Ltd.2020-12-10
Neuronaute (K202334)Bioserenity Sas2020-12-10
CD Horizon Spinal System Instruments (K203291)Medtronic Sofamor Danek USA, Inc.2020-12-08
BNA Platform (K202588)Elminda, Ltd.2020-12-07
NuVasive Navigation.S Instruments (K200719)Nu Vasive, Incorporated2020-12-02
Axonpen, Axonmonitor, Axonbox, Tablet (K201308)Clearmind Biomedical2020-11-27
Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 (K202470)Everyway Medical Instruments Co.,Ltd2020-11-25
DR-HO'S Electro Therapy Conductive Gel (K200402)Guangzhou Xinbo Electronic Co., Ltd.2020-11-25
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