Atlas FDA

Neurology

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

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RecordFirmDate
GIM-STIM OTC TENS/EMS System (K190988)Gemore Technology Co, Ltd.2019-08-16
ELAN 4 Tools (K183203)Aesculap, Inc.2019-08-09
7D Surgical System (K183276)7D Surgical, Inc.2019-08-07
Navigated Pedicle Access Kit (K191012)Izi Medical Products, LLC2019-08-07
EEG Electrode Template (K191225)Rhythmlink International, LLC2019-08-05
Leksell Vantage Stereotactic System (K190887)Elekta Instrument AB2019-08-01
Mini TENS Therapy Device (K182871)Shenzhen Jumper Medical Equipment Co., Ltd.2019-08-01
EyeBOX (K191183)Oculogica, Inc.2019-07-31
StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 (K190672)Medtronic Navigation, Inc.2019-07-31
Transcutaneous Electrical Nerve Stimulator (K183288)Shenzhen Kentro Medical Electronics Co., Ltd.2019-07-30
KLS Martin Individual Patient Solutions (IPS) Planning System (K182889)KLS-Martin L.P.2019-07-26
ExcelsiusGPS Spine 1.1 Interbody Module (K191100)Globus Medical, Inc.2019-07-24
Tech Dots - Adhesive and conductive gel (K190050)Spes Medica Srl2019-07-19
Anspach Helix Dissection Tools (K183545)The Anspach Effort, Inc.2019-07-19
Modus Nav (K183325)Synaptive Medical, Inc.2019-07-14
Nalu Lead Blank (50cm) (K190960)Boston Scientific Neuromodulation2019-07-11
Stryker PEEK Customized Cranial Implant Kit (K190229)Stryker2019-07-11
PressOn Electrode Headset (K190801)Rhythmlink International, LLC2019-07-10
Miethke Shunt System GAV 2.0 and SA 2.0 Valves (K190174)Aesculap, Inc.2019-07-05
Wrap accessory electrodes (K190617)Hi-Dow International, Inc.2019-07-02
NAVIO (K191223)Blue Belt Technologies, Inc.2019-06-28
Trevo XP ProVue Retriever (K190779)Stryker2019-06-25
JKH Stimulator Plus (K191151)Jkh USA, LLC2019-06-21
ReliefBand (K182960)Reliefband Technologies, LLC2019-06-21
Voyager Trajectory Array Guide (V-TAG) (K191400)Mri Interventions, Inc.2019-06-21
DB-CMF (K182742)Dimensional Bioceramics, LLC2019-06-20
MHD TENS (K190115)Minghuangda Electronic Co., Ltd.2019-06-19
Stryker MIS and Footed Attachments (K191049)Stryker Corporation2019-06-18
GALILEO Spine Alignment Monitoring System (K182524)MiRus, LLC2019-06-17
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments (K190172)Stryker2019-06-14
ELECTRODES PAD (K190700)Shenzhen Bestpad Technology Development Co., Ltd.2019-06-14
XenoSure Dura Biologic Patch (K183513)LeMaitre Vascular, Inc.2019-06-13
Avid IF2 (K183692)Vision Quest Industries Inc./Dba VQ Orthocare2019-06-12
Spine & Trauma Navigation (K191285)Brainlab AG2019-06-11
SPINEART Navigation Instrument System (K183630)Spineart SA2019-06-10
NeuroShield (K190246)Monarch Bioimplants GmbH2019-05-31
COMPLETE CONTROL System Gen2 (K191083)Coapt, LLC2019-05-24
Stealth-Midas MR8 System (K183644)Medtronic Powered Surgical Solutions2019-05-22
Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) (K182711)Kelyniam Global, Inc.2019-05-21
Nerivio Migra (DEN180059)Theranica Bioelectronics , Ltd.2019-05-20
Navigation Enabled Instruments (K183381)Stryker2019-05-17
MR8 Drill System, Midas Rex MR8 ClearView Tools (K183515)Medtronic Powered Surgical Solutions2019-05-12
SPEAC System (K182180)Brain Sentinel, Inc.2019-05-11
Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator (K190504)Relievant Medsystems2019-05-03
TruDi NAV Wire (K190532)Acclarent, Inc.2019-05-03
Portable Electro-Stimulation Therapy Device (K182108)Guangzhou Longest Science & Technology Co., Ltd.2019-04-26
Comaneci, Comaneci Petit, Comaneci 17 (DEN170064)Rapid-Medical , Ltd.2019-04-24
Monarch eTNS System (DEN180041)Neurosigma, Inc.2019-04-19
Ultra OTC Facial Toning System (K183189)Micro Current Technology, Inc.2019-04-17
D-Clip; D-Clip Applier (K180757)Peter Lazic GmbH2019-04-12
ExcelsiusGPS (K190653)Globus Medical, Inc.2019-04-09
Dome Electrode (K190416)Coapt, LLC2019-04-04
HORIZON TMS Therapy System with Navigation (K183376)Magstim Company, Ltd.2019-04-03
DAEHAN Disposable CUP Electrodes (K180232)Daehan Medical Systems Co., Ltd.2019-04-03
Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits (K183579)Boston Scientific Neuromodulation2019-03-29
Freedom Spinal Cord Stimulator (SCS) System (K182720)Stimwave Technologies Incorporated2019-03-29
Leica FL400 (DEN180024)Leica Microsystems (Schweiz) AG2019-03-28
SM Electrodes (K183154)Hong Qiangxing (Shenzhen) Electronics Limited2019-03-26
Nalu Neurostimulation System (K183047)Boston Scientific Neuromodulation2019-03-22
ROSA ONE Spine application (K182848)Medtech S.A2019-03-22
Nexstim Navigated Brain Therapy (NBT) System 2 (K182700)Nexstim Plc2019-03-22
AE-120A EEG Head Set (K183529)Nihon Kohden Corporation2019-03-19
HORIZON TMS Therapy System (K182853)Magstim Company, Ltd.2019-03-15
HIVOX OTC Electrical Stimulator (K190347)Hivox Biotek, Inc.2019-03-15
JKH Stimulator Plus (K182203)Jkh USA, LLC2019-03-14
L300 Go System (K190285)Bioness, Inc.2019-03-14
AirRay Subdural Cortical Electrodes (K183437)Cortec GmbH2019-03-12
Nitinol Thermocouple (TCN) Electrode (K183177)Boston Scientific Corporation2019-03-08
Brainsway Deep TMS System (K183303)Brainsway , Ltd.2019-03-08
Rulo Radiofrequency Lesion Probe (K190256)Epimed International, Inc.2019-03-08
Cervella (K182311)Innovative Neurological Devices, LLC2019-03-07
Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) (K181807)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2019-03-06
PAT (Pain Alleviation Technologies) (K182267)Marchan Medical, LLC2019-02-27
SpringTMS (K182976)Eneura®, Inc.2019-02-25
The EPAD 2 System (K182542)Safeop Surgical, Inc.2019-02-22
BrainScope TBI (Model: Ahead 400) (K183241)Brainscope Company, Inc.2019-02-19
TMS-Cobot TS MV (K182768)Axilum Robotics2019-02-17
Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker (K183196)Stryker Corporation2019-02-14
ROSA ONE Brain Application (K182417)Medtech S.A2019-02-07
AQrate Robotic Assistance System (K182000)Globus Medical, Inc.2019-01-29
Solitaire 4 Revascularization Device (K183022)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2019-01-29
ROSA Knee System (K182964)Orthosoft Inc (D/B/A Zimmer Cas)2019-01-24
Codman Disposable Perforators (K183581)Integra Lifesciences Corp.2019-01-20
ELAN 4 Tools (K182527)Aesculap, Inc.2019-01-19
Aurora Surgiscope System (K182211)Rebound Therapeutics Corporation2019-01-18
Esprit Nova (K182227)Neurozone Msh Incorporated2019-01-17
DL Self-adhesive Electrode (K182111)Shaoxing DL Healthcare Co., Ltd.2019-01-17
CereLink ICP Monitor, CereLink ICP Extension Cable (K183406)Integra Lifesciences Corp.2019-01-11
Maxpower Relief (K182120)Omron Healthcare, Inc.2019-01-10
Choice Spine Navigation System (K182721)Choicespine, LP2019-01-08
BridalVeil Navigated Instruments (K182982)Astura Medical2019-01-04
Optimus Neuro System (K183352)Osteonic Co., Ltd.2019-01-02
ClearUP Sinus Pain Relief (K182025)Tivic Health Systems, Inc.2019-01-02
Polaris RF Ablation System (K181864)Baylis Medical Company, Inc.2019-01-02
EyeBOX (DEN170091)Oculogica, Inc.2018-12-28
Embrace (K181861)Empatica S.r.l.2018-12-20
microTargeting Guideline 4000 5.0 System (K183123)FHC, Inc.2018-12-20
Modified BrainScope One (K181785)Brainscope Company, Inc.2018-12-19
NuFACE FIX Skin Toning Device (K182424)Carol Cole Company Dba Nuface2018-12-18
reSET-O (K173681)Pear Therapeutics, Inc.2018-12-10
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