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Neurology

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

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RecordFirmDate
Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 (K162517)Jkh Health Co., Ltd.2017-04-14
Coolief* Cooled RF Probe (K163461)Halyard Health, Inc.2017-04-13
Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes (K163355)Ad-Tech Medical Instrument Corporation2017-04-12
MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 (K163547)Neurovirtual USA, Inc.2017-04-11
REMbrandt (K163617)Embla Systems2017-04-11
Neurovision Nerve Locator Monitor (Nerveana), EMGView Software (K170677)Neurovision Medical Product, Inc.2017-04-05
ExactechGPS Total Shoulder Application, Equinoxe Planning Software (K162567)Blue Ortho2017-04-05
Mazor X (K163221)Mazor Robotics , Ltd.2017-04-04
EnsoSleep (K162627)Ensodata, Inc.2017-03-31
MEP Monitor (K162873)Tonica Elektronik A/S2017-03-31
StealthStation S8 System Platforms and StealthStation Cranial Software (K162309)Medtronic Navigation, Inc.2017-03-31
V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System (K162999)MicroVention, Inc.2017-03-29
MR8 Drill System (K163565)Medtronic Powered Surgical Solutions2017-03-28
Cleveland Multiport Ventricular Catheter Set (K161731)Parker Hannifin Corp.2017-03-27
iovera system (K161835)Myoscience, Inc.2017-03-24
MEDICON Spinal Spreading Systems (K161680)Medicon EG2017-03-24
Eclipse with VEMP (K162037)Interacoustics A/S2017-03-23
Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories (K163182)Medtronic Powered Surgical Solutions2017-03-23
Synapsys Ulmer Video Nystagmograph (K163558)Synapsys SA2017-03-23
Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems (K161318)Tedan Surgical Innovations, LLC2017-03-20
TIPCAM 1S 3D System (K162880)Karl Storz Endoscopy America, Inc.2017-03-16
Navigated Instrument System (K162921)Orthofix, Inc.2017-03-13
Rapid2 Therapy System (K162935)Magstim Company, Ltd.2017-03-10
TSolution One Surgical System Model 210 (K170430)THINK Surgical, Inc.2017-03-06
Intellijoint HIP Generation 2A System (K162364)Intellijoint Surgical, Inc.2017-03-02
KneeAlign 2 System (K163379)Orthalign, Inc.2017-03-02
Cascade IOMAX Intraoperative Monitor (K162199)Cadwell Industries, Inc.2017-03-02
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System (K161853)Aesculap, Inc.2017-02-27
ZIIP Device (K161484)Ziip,Llc2017-02-24
ImPACT (K170209)Impact Applications, Inc.2017-02-23
TZ SKULL PIN Adult (K163322)Tz Medical, Inc.2017-02-23
Stryker OrthoMap Versatile Hip System (K162937)Stryker Corporation2017-02-23
Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker (K162929)Stryker Corporation2017-02-22
Companion (DEN140033)Lgch, Inc.2017-02-16
Fiagon Navigation – PointerTube Straight and PointerTube Keat (K163416)Fiagon GmbH2017-02-16
Scopis Hybrid Navigation System EM (K161491)Scopis GmbH2017-02-09
Smart Pain Reliever, Model LT5019 (K162479)Shenzhen Dongdixin Technology Co., Ltd.2017-02-08
EndyGel (K161715)Endymed Medical, Ltd.2017-02-07
Micro-current Wrinkle Reduction Facial service, model EP-400 (K162106)Li-Tek Electronic Technology Corporation2017-02-03
RehaStim 2 (K162683)Hasomed GmbH2017-02-03
L300 Go System (K162407)Bioness, Inc.2017-01-27
OrthAlign Plus System (K162962)Orthalign, Inc.2017-01-23
Cranial PSI (K161090)Ossdsign AB2017-01-19
Polysmith Sleep System, Model NTI7593 (K161650)Neurotronics, Inc.2017-01-19
STIMPOD NMS460 Nerve Stimulator (K161091)Xavant Technology (Pty), Ltd.2017-01-18
Taps for Resorbable Screws (K153587)Synthes (USA) Products, LLC2017-01-18
WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A (K162663)Well-Life Healthcare Limited2017-01-17
Cantab Mobile (K161328)Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd.2017-01-13
OsteoVation Impact (K162864)Skeletal Kinetics, LLC2017-01-13
SpineGuard DSG Zavation Screw System (K162884)Spineguard S.A.2017-01-12
DuraGen Secure Dural Regeneration Matrix (K163456)Integra LifeSciences Corporation2017-01-06
NeuraGen 3D Nerve Guide Matrix (K163457)Integra LifeSciences Corporation2017-01-06
Axium Prime Detachable Coil System (K162704)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2017-01-03
NuFACE Gel Primer (K161654)Carol Cole Company2016-12-30
Cranial Reducing Tubes (K162604)Medtronic Navigation, Inc.2016-12-30
Envision 3D: Image Guidance System (K162375)7D Surgical, Inc.2016-12-29
Neurosoft TMS (K160309)Teleemg, LLC2016-12-22
DMS Disposable Subdermal Needle Electrodes (K161566)Daehan Medical Systems Co., Ltd.2016-12-21
CP Relief Wand-OTC (K162630)Mid-America Medical Innovations, LLC2016-12-20
CustomizedBone Service (K160707)Fin-Ceramica Faenza S.P.A.2016-12-17
COOLIEF Cooled Radiofrequency Kit (K163236)Halyard Health, Inc.2016-12-16
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit (K162161)Stimwave Technologies Incorporated2016-12-16
XLTEK EMU40EX EEG Headbox (K163163)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2016-12-14
Stryker Universal Mesh (K161821)Stryker2016-12-08
CRW STEREOTACTIC SYSTEM (K160811)Integra LifeSciences Corporation2016-12-06
WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A (K161453)Well-Life Healthcare Limited2016-12-05
Phasor Drill (K161704)Biotex, Inc.2016-12-01
RemLogic (K162140)Embla Systems2016-12-01
Fiagon Navigation System (K162176)Fiagon GmbH2016-12-01
Electronic Pulse Stimulator (K160508)Beijing Choice Electronic Technololgy Co., Ltd.2016-11-21
Solitaire 2 Revascularization Device (K162539)Micro Therapeutics, Inc. d/b/a ev3 Neurovascular2016-11-10
Cadwell AmpliScan (K161027)Cadwell Industries, Inc.2016-11-08
Trex_HD (K162595)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2016-11-04
Durepair Dura Regeneration Matrix (K161370)Medtronic Neurosurgery2016-11-02
AxoGuard Nerve Connector (K162741)Cook Biotech Incorporated2016-10-31
FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W (K161282)Medico Electrodes International , Ltd.2016-10-30
Codman EDS3 CSF External Drainage System (K162437)Codman & Shurtleff, Inc.2016-10-28
Smart External Drain (SED) System (K161605)Aqueduct Critical Care, Inc.2016-10-27
Acclarent NavWire Sinus Navigation Guidewire (K161697)Acclarent, Inc.2016-10-24
CARTO ENT System (K161701)Biosense Webster2016-10-24
KARL STORZ NAV1 Electromagnetic Navigation System (K161555)Karl Storz Endoscopy America, Inc.2016-10-21
HICP200 Patient/Monitor Interconnect Cable (K161010)Innerspace Neuro Solutions, Inc.2016-10-20
TENS Electrodes (K160081)Cathay Manufacturing Corp.2016-10-19
OTC TENS Device, Model PTS-IV (K161537)Counter Scientific Development (Gz), Ltd.2016-10-13
Stryker OrthoMap Precision Knee system (K162341)Stryker Leibinger GmbH & Co KG2016-10-12
SimulCare II(TM) (K160246)Xanacare Technologies, LLC2016-10-06
Painmaster MCT Patch (K151995)Newmark, Inc.2016-10-05
Biopor Porous Polyethylene Implants (K161446)Ceremed , Inc.2016-09-27
VSP Cranial System (K151285)3D Systems, Inc.2016-09-23
Ahead 300 (K161068)Brainscope Company, Inc.2016-09-22
Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems (K161992)Integra LifeSciences Corporation2016-09-22
Personal Kinetigraph (PKG) System (K161717)Gkc Manufacturing Pty, Ltd.2016-09-20
Guidewire 0.6 Single Use (K161940)Fiagon GmbH2016-09-18
KARL STORZ Flexible Video-Neuro-Endoscope System (K161112)KARL STORZ Endoscopy-America, Inc.2016-09-17
HBOTC Muscle and Nerve Stimulator (K160255)Hb Medical, Inc.2016-09-15
TSolution One Cup1 Surgical System (K162195)THINK Surgical, Inc.2016-09-14
StealthStation System with Cranial Software (K153660)Medtronic Navigation, Inc.2016-09-14
NeuroStar TMS Therapy System (K161519)Neuronetics, Inc.2016-09-11
Self-retaining Retractor (K161004)Fetzer Medical GmbH & Co. KG2016-09-09
Symmetry Sharp Kerrison Rongeur (K161744)Symmetry Surgical, Inc.2016-09-07
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