Atlas FDA

Neurology

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

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RecordFirmDate
Wallaby Avenir Coil System (K173711)Wallaby Medical, Inc.2018-05-04
Brainsway Deep (DTMS) System (K173540)Brainsway , Ltd.2018-05-03
7D Surgical System (K180352)7D Surgical, Inc.2018-05-02
Drug Relief (K173861)Dyansys, Inc.2018-05-02
Spineology Navigation Instruments (K180796)Spineology, Inc.2018-05-02
ADAPT for Gamma3 (K173946)Stryker GmbH2018-05-02
Mazor X (K180307)Mazor Robotics , Ltd.2018-04-30
NeuroCap (K172866)Memory MD, Inc.2018-04-27
OLYMPIC Navigated Instruments (K172166)Astura Medical2018-04-27
2 Face / Face Evolution (K171821)Heat IN A Click2018-04-26
Cala ONE (DEN170028)Cala Health, Inc.2018-04-26
neuromate Gen III (K180206)Renishaw Mayfield Sarl2018-04-24
Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter (K180277)Smith & Nephew, Inc.2018-04-24
Reaxon Plus (K180222)Medovent GmbH2018-04-24
XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) (K172887)Guangzhou Xinbo Electronic Co., Ltd.2018-04-19
EV-804 OTC Pain Relief TENS (K172919)Everyway Medical Instruments Co.,Ltd2018-04-19
encevis (K171720)Ait Austrian Institute of Technology GmbH2018-04-19
TENS device-EmeTerm, CinvStop (K172478)Wat Medical Technology (Ningbo) Co., Ltd.2018-04-19
KARL STORZ ICG Imaging System (K180146)Karl Storz Endoscopy America, Inc.2018-04-17
WR19 System (K172735)Zeto, Inc.2018-04-17
Aesculap Slim Clip Applier (K180914)Aesculap, Inc.2018-04-17
Penumbra Coil 400, Ruby Coil System, POD System (K173614)Penumbra, Inc.2018-04-17
NAVIO™ Surgical System (NAVIO system) (K180271)Blue Belt Technologies, Inc.2018-04-06
gammaCore Sapphire (K180538)Electrocore, LLC2018-03-30
eego amplifiers (K172312)Eemagine Medical Imaging Solutions GmbH2018-03-30
ROSA BRAIN (v3.0.0.5) (K172444)Medtech S.A2018-03-28
ThermoNeuroModulation Device, TNM Device (DEN170023)Scion Neurostim, LLC2018-03-26
EKOS ultrasound EVD Device, EVD Control Unit (K172035)Btg International, Inc.2018-03-24
Longeviti PMMA Static Cranial Implant (K170410)Longeviti Neuro Solutions, LLC2018-03-23
Element System with IBT Electrodes (K173571)Infinite Biomedical Technologies, LLC2018-03-21
ARTAS System (K173358)Restoration Robotics, Inc.2018-03-16
Natus NeuroWorks (K180421)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2018-03-14
Acclarent ENT Navigation System (K173628)Acclarent, Inc.2018-03-10
Grass TWin (K173690)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2018-03-09
L300 Go System (K173682)Bioness, Inc.2018-03-09
Navigated Instrument System (K172115)Orthofix, Inc.2018-03-08
ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) (K171802)Bayer Healthcare, LLC2018-03-07
Microscope Navigation Software (K172820)Brainlab AG2018-03-01
STARband, STARlight, St. Louis Band (K180109)Orthomerica Products, Inc.2018-03-01
iovera system (K173763)Myoscience, Inc.2018-02-28
S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D (K173186)Everyway Medical Instruments Co.,Ltd2018-02-28
NeuroNav System, NeuroSmart System (K172042)Alpha Omega Engineering , Ltd.2018-02-27
Natus Quantum (K180181)Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek)2018-02-22
Optima Coil System (K172390)Blockade Medical, LLC (D.B.A. Balt Usa)2018-02-18
NeuroEEG (K173460)Memory MD, Inc.2018-02-16
AtriCure cryoICE cryo-ablation probe (CRYO2) (K180138)AtriCure, Inc.2018-02-15
Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) (K173352)Concentric Medical, Inc.2018-02-15
Micromed BRAIN QUICK system (K171384)Micromed S.P.A.2018-02-01
ODFS Pace XL (K171396)Odstock Medical, Ltd.2018-01-31
SedLine Sedation Monitor (K172890)Masimo Corporation2018-01-26
Embrace (K172935)Empatica S.r.l.2018-01-26
gammaCore-S (K173442)Electrocore, LLC2018-01-23
Navigated INFINITY™ Instruments (K173338)Medtronic Sofamor Danek USA, Inc.2018-01-18
K2M Navigation Instruments (K171556)K2m2018-01-16
Electrodes with snap / Electrodes with pigtail (K171722)Shenzhen Konmed Technology Co., Ltd.2018-01-10
PreOp (K172858)Epilog2018-01-08
Electrodes with silver conductive (K171721)Shenzhen Konmed Technology Co., Ltd.2018-01-05
Spineology Navigation Instruments (K172518)Spineology, Inc.2018-01-05
NEURONAUTE (K170138)Bioserenity2017-12-26
SurgeoBite (K172978)Surgovations, LLC2017-12-22
Neuro Omega System (K171581)Alpha Omega Engineering , Ltd.2017-12-22
NuVasive Navigation Instruments (K172623)Nu Vasive, Incorporated2017-12-21
Ives MR Conditional Cup Electrode (K171102)Ives Egg Solutions2017-12-21
Pobling MIITY 2 (K163550)Habalan Med & Beauty Co.,Ltd2017-12-20
Zmachine Synergy (K172986)Consolidated Research of Richmond, Inc. Dba General Sleep CO2017-12-19
eVox System (K171781)Evoke Neuroscience, Inc.2017-12-13
Adhesive Electrodes (K171381)Shenzhen Quality Medical Technology Co.,Ltd2017-12-13
Neurosoft TMS (also CloudTMS) (K173441)Teleemg, LLC2017-12-13
Wireless Pain Relieve Device Model: LT5018C (K173462)Shenzhen Dongdixin Technology Co., Ltd.2017-12-08
Craniomaxillofacial Distraction System (CMFD) (K170818)Synthes USA Products, LLC2017-12-07
gammaCore-2 (K172270)Eletrocore, LLC2017-12-07
MR Conditional Cup Electrode, MR Conditional Webb Electrode (K172503)Rhythmlink International, LLC2017-12-01
Foot Drop System (Model XFT-2001D) (K162718)Shenzhen Xft Medical Limited2017-11-30
ReliefBand 1.5 (K173233)Reliefband Technologies2017-11-30
HIVOX OTC Electrical Stimulator (K171803)Hivox Biotek, Inc.2017-11-29
Cefaly Dual (K173006)Cefaly Technology2017-11-28
Cerafix Dura Substitute (K172603)Acera Surgical, Inc.2017-11-27
DIXI Medical Microdeep Depth Electrode (K170959)Dixi Medical2017-11-24
ExactechGPS Total Shoulder Application (K173372)Blue Ortho2017-11-24
I-Portal Portable Assessment System - Nystagmograph (I-PAS) (K171884)Neuro Kinetics, Inc.2017-11-22
OrthAlign Plus System (K172462)Orthalign, Inc.2017-11-22
Dr.MUSIC 3s (K172451)Smartmedicaldevice Co., Ltd.2017-11-17
Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray (K172849)Intellijoint Surgical, Inc.2017-11-16
NSS-2 System (DEN170018)Innovative Health Solutions (Ihs), Inc.2017-11-15
Smart External Drain (SED) System (K172759)Aqueduct Critical Care, Inc.2017-11-14
Stryker Universal Mesh (K170725)Stryker2017-11-13
Disposable Snap Electrode (K172703)Embla Systems2017-11-13
Nexstim Navigated Brain Therapy (NBT) System 2 (K171902)Nexstim Plc2017-11-10
Aesculap Slim Clip Applier Forceps (K173271)Aesculap, Inc.2017-11-10
Alivio Ventricular Catheter and Flusher System (Alivio System) (K172006)Alcyone Lifesciences, Inc.2017-11-09
CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit (K173192)Codman & Shurtleff, Inc.2017-11-08
Comet-PLUS (K172711)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2017-11-03
Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base (K172644)Stimwave Technologies Incorporated2017-11-03
Mako Partial Knee Application (K172301)Mako Surgical Corp.2017-11-02
Mytens Model: BW-TSX (K171026)Bewell Connect Corp.2017-11-01
iFuse Implant System- iFuse Navigation (K172268)SI-BONE, Inc.2017-10-31
Intellijoint HIP Generation 2B System (K171525)Intellijoint Surgical, Inc.2017-10-30
Smart Photon Micro-current Device, Model: EP-300 (K162652)Li-Tek Electronic Technology Corporation2017-10-25
BeneLife Premium Facial Treatment Pack, Model: QZ0701A (K171647)Infinitus (China) Company , Ltd.2017-10-23
ClearPoint System (K171257)Mri Interventions, Inc.2017-10-20
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