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Neurology

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

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RecordFirmDate
DOLPHIN NEUROSTIM OTC (K133789)Acumed Medical , Ltd.2015-03-04
NIHON KOHDEN AE-918P NEURO UNIT (K130238)Nihon Kohden Corp.2015-03-04
ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM (K141123)Alliance Partners, LLC2015-02-27
V-GUIDE FOR VENTRICULOSTOMIES (K141559)Arc Surgical, LLC2015-02-27
AESCULAP ORTHOPILOT NEXT GENERATION (K141694)Aesculap Implant Systems, LLC2015-02-24
StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit (K142432)Bioness, Inc.2015-02-20
Codman Certas Plus Programmable Valve; Codman Certas Toll Kit (K143111)Medos International SARL2015-02-19
Polysmith Sleep System (K142774)Neurotronics, Inc.2015-02-18
COGNISION EEG/EP SYSTEM (K141316)Neuronetrix Solutions2015-02-13
GALILEO NT (K142064)Eb Neuro S.P.A.2015-02-13
Navigated Vertex Select Instruments (K143628)Medtronic Sofamor Danek USA, Inc.2015-02-12
OPTIMUS NEURO SYSTEM (K141911)Osteonic Co., Ltd.2015-02-10
BWMINI EEG, BWMINIHST, BWMINI PSG (K131335)Neurovirtual USA, Inc.2015-02-03
Myoscience iovera system (K142866)Myoscience, Inc.2015-01-21
Zmachine (K142825)Consolidated Research of Richmond, Inc.2015-01-20
COLLAGEN DURA MEMBRANE (K141608)Collagen Matrix, Inc.2015-01-16
Medical Monofilament Sensory Screening Toool (K143068)Medical Monofilament Manufacturing2015-01-14
INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS (K140722)Integra LifeSciences Corporation2015-01-06
OWL CANNULAE (K141586)Diros Technology, Inc.2014-12-30
CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable (K142429)Codman & Shurtleff, Inc.2014-12-24
SPEEDY FLAP SYSTEM (K130447)Jeil Medical Corporation2014-12-22
StimPad OTC (K142686)Aemed, Inc.2014-12-18
LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM (K140680)Alpine Biomed Aps2014-12-12
NAVIGABLE BRAIN BIOPSY CANNULA SET (K140705)Izi Medical Products2014-12-05
MAXPOWER RELIEF (K141978)Omron Healthcare, Inc.2014-12-03
5000Z FIREFLY SYSTEM (K133502)Prizm Medical, Inc.2014-12-03
Atricure Cryo Module System; cryoICE cryoablation probe (K142203)AtriCure, Inc.2014-11-25
MAYFIELD Skull Clamp (K142238)Integra LifeSciences Corporation2014-11-24
SUDOSCAN (K141872)Impeto Medical, Inc.2014-11-21
BrainScope Ahead 100 (DEN140025)Brainscope Company, Inc.2014-11-17
ASCEND ELECTRODE (K140586)Neurometrix, Inc.2014-11-17
CUTANEOUS ELECTRODES (K142099)Bio Protech, Inc.2014-11-17
WEARABLE THERAPY GARMENTS (K141342)Axiobionics, LLC2014-11-14
GARMENT ELECTRODES (K141076)Shenzhen Dongdixin Technology Co., Ltd.2014-11-14
MINOP Disposable Introducer 26F (K142315)Aesculap, Inc.2014-11-14
OTC COMBO TENS/EMS SYSTEM (K141299)Well-Life Healthcare Limited2014-11-14
MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM (K141989)Mako Surgical Corporation2014-11-13
Barricade Embolization Coil System (K142513)Blockade Medical2014-11-13
HEALTH EXPERT ELCTRONIC STIMULATOR (K133929)Shenzhen Osto Technology Company Limited2014-11-12
INNOVASIS CRANIAL SYSTEM (K141644)Innovasis, Inc.2014-11-07
ZANZA-CLICK (DEN130019)Tecnimed S.R.L.2014-11-07
ZAP-IT! (DEN100024)Ecobrands , Ltd.2014-11-07
E-Shield Multi-paried Subdermal Needle Electrodes (K142470)Neuroinvent, Inc.2014-11-05
SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D (K141941)Stryker Corporate2014-10-31
UNIVERSAL NAVIGATION INSTRUMENTS (K140927)Medos International SARL2014-10-24
QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT (K141869)Hemedex Incorporated2014-10-10
FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM (K141399)Stimwave Technologies Incorporated2014-10-10
THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL (K141456)Fiagon GmbH2014-10-08
STARBAND, STARLIGHT (K141842)Orthomerica Products, Inc.2014-10-06
CRANIOPLUG (K140309)Ossdsign AB2014-10-03
MEDLINE NEURO SPONGE (K140369)Medline Industries, Inc.2014-09-26
ELECTRONIC PULSE STIMULATOR (K141260)Shenzhen Jingkehui Electronic Co.., Ltd.2014-09-17
IASSIST KNEE SYSTEM (K141601)Zimmer Cas2014-09-11
RENAISSANCE X SYSTEM (K140167)Mazor Robotics , Ltd.2014-09-10
PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES) (K141551)Stryker Corporate2014-09-08
HFD100 ROCKER ARM ACCESSORY (K141950)Imris, Inc.2014-09-04
EASYSTIM TN28_OTC (K140168)Easymed Instruments Co., Ltd.2014-08-28
TENS (K133979)Sunmas (H.K.) Trading Limited2014-08-26
IKNEE DISTAL FEMORAL CUTTING GUIDE (K140689)Evergreen Orthopedic Research Lab2014-08-22
ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, (K141446)Natus Medical Incorporated2014-08-22
PERSONAL KINETIGRAPH (PKG) SYSTEM (K140086)Gkc Manufacturing Pty, Ltd.2014-08-22
Medtronic DUET External Drainage and Monitoring System (DEN120017)Medtronic Neurosurgery2014-08-22
CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM (K140585)Curexo Technology Corporation2014-08-18
WALKAIDE SYSTEM (K140886)Innovative Neurotronics, Inc.2014-08-08
IQ TECHNOLOGIES (K131290)Iq Technologies, Inc.2014-08-06
BNA ANALYSIS SYSTEM (K121119)Eiminda , Ltd.2014-07-25
STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM (K133444)Medtronic Navigation, Inc.2014-07-25
HIVOX SELF ADHESIVE ELECTRODE GEL PADS (K131720)Hivox Biotek, Inc.2014-07-25
DYNAMIC NEUROSCREENING DEVICE (K141208)Prosenex2014-07-23
CADWELL SPIKE AND SEIZURE DETECTOR (K140552)Cadwell2014-07-23
INTELLIJOINT HIP (K133759)Intellijoint Surgical, Inc.2014-07-23
BABYMEG BIOMAGNETOMETER SYSTEM (K133419)Tristan Technologies, Inc.2014-07-21
E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES (K140200)Neuroinvent, Inc.2014-07-18
SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY (K131513)Ritm Okb Zao2014-07-11
NEUROPACE BURR HOLE COVER (K141368)NeuroPace, Inc.2014-07-11
NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS (K131923)Techlink International2014-07-03
ASCEND (K140333)Neurometrix, Inc.2014-07-03
POD SYSTEM (K141134)Penumbra, Inc.2014-07-03
NAVIO (K140596)Blue Belt Technologies, Inc.2014-07-02
LEFORTE NEURO SYSTEM BONE PLATE AND SCREW (K141452)Jeil Medical Corporation2014-07-02
HICUT HIGHSPEED INSTRUMENT (K130755)Adeor Medical AG2014-06-27
HIVOX ELECTRIC STIMULATOR OTC TENS (K140650)Hivox Biotek, Inc.2014-06-27
MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM) (K140462)Synthes (USA) Products, LLC2014-06-13
ORTHALIGN PLUS SYSTEM (K140331)Orthalign, Inc.2014-06-10
STARBAND AND STARLIGHT (K140353)Orthomerica Products, Inc.2014-06-06
STRYKER KWIC NEEDLE (K140868)Orthovita, Inc.2014-06-05
AXON-BUS PROSTHETIC SYSTEM (K123795)Otto Bock Austria2014-06-03
CP RELIEF WAND (K133779)Mid-America Medical Innovations, LLC2014-05-30
REHASTIM 2, ERIGOPRO (FES) (K132416)Hasomed GmbH2014-05-28
DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM (K140038)Curexo Technology Corporation2014-05-27
Best-AV2 Pro-Sport(tm) (K123099)Avazzia, Inc.2014-05-23
NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS (K140454)Medtronic Sofamor Danek USA, Inc.2014-05-22
SPRINGTMS TOTAL MIGRAINE SYSTEM (K140094)Eneura Therapeutics, LLC2014-05-21
SKINTACT (K140340)Leonhard Lang GmbH2014-05-21
OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE (K133082)Osteosymbionics, LLC2014-05-20
PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE (K133793)Persyst Development Corporation2014-05-19
SWIFT-LOCK ANCHOR (K140272)St Jude Medical2014-05-02
FIAGON NAVIGATION SYSTEM (K133573)Fiagon GmbH2014-04-30
BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE (K130065)Biosonic Technologies, LLC2014-04-30
NEUROMATE FRAMELESS GEN II (K132755)Renishaw Mayfield Sarl2014-04-29
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