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Neurology

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

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RecordFirmDate
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS (K072208)Integra LifeSciences Corporation2007-09-07
GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE (K071118)Ives Eeg Solutions, Inc.2007-09-07
ALPHAONE BIOFEEDBACK SYSTEM (K071661)Telediagnostic Systems, Inc.2007-09-05
COMFY SERIES: EV-804, EV-805 & EV-806 (K071951)Everyway Medical Instruments Co.,Ltd2007-09-05
LORENZ BIOTECH APTIVA, VERSION 2.13 (K061828)Lorenz Biotech S.P.A.2007-08-24
SPINEASSIST SYSTEM (K063607)Mazor Surgical Technologies , Ltd.2007-08-23
DURAGEN XS DURAL REGENERATION MATRIX (K072207)Integra Lifesciences Corp.2007-08-23
DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 (K063729)Technomed Europe2007-08-21
RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715 (K063836)Medtronic Neurosurgery2007-08-16
CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM (K071138)Prosurg, Inc.2007-08-15
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM (K071505)Integra LifeSciences Corporation2007-08-06
NEUROPORT ELECTRODE (K070272)Cyberkinetics Neurotechnology Systems, Inc.2007-08-03
INSTRUMED RETRACTORS (K071771)Instrumed International, Inc.2007-08-02
PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM (K070731)Plus Orthopedics AG2007-07-31
MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 (K071791)Codman & Shurtleff, Inc.2007-07-30
MAXINSIGHT (K070358)Eemagine Medical Imaging Solutions GmbH2007-07-30
COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65 (K071821)Tonica Elektronik A/S2007-07-27
ANEUROPLASTIC, MODEL 43-1290 (K071776)Codman & Shurtleff, Inc.2007-07-26
MICROTARGETING GUIDELINE 4000 (K071364)FHC, Inc.2007-07-25
MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE (K071300)Smith & Nephew, Inc.2007-07-20
NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 (K071714)Orthosoft, Inc.2007-07-20
BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE (K071745)Baylis Medical Co., Inc.2007-07-19
SMARTEP, MODEL M010000 (K070608)Intelligent Hearing Systems2007-07-18
EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101) (K070299)Ezfit Technology, Inc.2007-07-16
VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM (K071640)Cook, Inc.2007-07-12
MODIFICATION TO:CONTOUR SE MICROSPHERES (K071634)Boston Scientific Corp2007-07-12
WELLNESSPRO 2010 (K062616)Intelsource Group, Inc.2007-07-06
RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 (K071113)Restorative Therapies, Inc.2007-07-05
PRESSIO ICP MONITORING SYSTEM (K062584)Sophysa SA2007-07-05
CRANIAL SOLUTION ORTHOSIS (K063133)Cranial Solutions2007-07-02
DEPUY CAS HEMI ASR HIP INSTRUMENTS (K071334)DePuy Orthopaedics, Inc.2007-07-02
EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 (K070890)Everlife Medical Equipment Co., Ltd.2007-06-29
INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) (K070696)Interacoustics A/S2007-06-29
GFX NERVE ABLATION SYSTEM (K063753)Aci, Inc.2007-06-20
BIS EEG MONITOR VIEW (K062613)Aspect Medical Systems, Inc.2007-06-18
HYDROCOIL EMBOLIC SYSTEM (HES) (K070656)MicroVention, Inc.2007-06-15
MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM (K070901)Bioplate, Inc.2007-06-15
STOCKERT NEURO N50, MODEL12267 (K070336)Stockert GmbH2007-06-14
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS (K071458)Integra LifeSciences Corporation2007-06-13
SACS EEG WORKSTATION A7 (K071109)Sacs Medical AB2007-06-07
MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR (K071246)Micrus Endovascular Corporation2007-06-01
MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE (K071185)Ambu A/S2007-05-30
FLEX ARM RETRACTOR SYSTEM (K071338)Koros USA, Inc.2007-05-29
RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D (K071173)Ossur Americans (Formerly the Jerome Group)2007-05-25
RHYTHM TOUCH Q 2-WAY (K063743)Shockim Enterprises, Ltd.2007-05-24
CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES (K070807)Pepin Mfg., Inc.2007-05-23
DEPUY CI HIP INSTRUMENTATION (K071135)DePuy Orthopaedics, Inc.2007-05-23
STRYKER INTRADISCAL RF GENERATOR (K063489)Synergetics, Inc.2007-05-23
DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS (K063494)Pro-Med Instruments GmbH2007-05-21
POLYSMITH SLEEP SYSTEM, MODEL NTI5498 (K062943)Neurotronics, Inc.2007-05-09
TOP-RANK ADHESIVE ELECTRODE (K070612)Top-Rank Health Care Equipment Co., Ltd.2007-05-07
BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1 (K062641)Avazzia, Inc.2007-04-30
STRYKER TWIST DRILLS (K070876)Stryker Craniomaxillofacial2007-04-27
NEWLIFE SCIENCES LLC, MODEL TMR (K070474)Newlife Sciences, LLC2007-04-25
FX DETACHABLE COIL SYSTEM (K060747)Micro Therapeutics, Inc.2007-04-24
VV FLUORO 3D (K070106)Brainlab AG2007-04-23
KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS (K060915)Kirwan Surgical Products, Inc.2007-04-17
MICROBLADE SHAVER AND ACCESSORIES (K063231)Baxano, Inc.2007-04-16
RS-4I MUSCLE STIMULATOR FAMILY (K062325)Rs Medical2007-04-13
TRIAL CABLE, 3009 (K070847)Advanced Neuromodulation Systems2007-04-11
STATIC CRANIOPLASTY ORTHOSIS (K063098)Boston Brace Intl., Inc.2007-04-11
MICRUS MICROCOIL SYSTEM (K070707)Micrus Endovascular Corporation2007-04-06
KINESIA (K063872)Cleveland Medical Devices, Inc.2007-04-06
CES ULTRA (K062284)Neuro-Fitness, LLC2007-04-05
ARGOS (K061479)3D Line Medical Systems S.R.L.2007-04-05
ELIBRA DYNAMIC KNEE BALANCER (K070108)Synvasive Technology, Inc.2007-04-04
BALANCEBACK MOBILE INTUITIVE VNG SYSTEM (K070729)Fall Prevention Technologies, LLC2007-03-30
PORTI 7 PHYSIOLOGICAL AMPLIFIER (K063599)Tms International BV2007-03-22
QUADRA BLOC TENS, MODEL 101 (K062547)Gradient Technologies, LLC2007-03-21
ULTRA LOW PROFILE RONGEUR (K062711)Baxano, Inc.2007-03-07
CTLOGICS NAVIGATIONS SYSTEMS (K063408)Praxim Medivision, SA2007-02-28
TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL (K062946)Top Corp.2007-02-15
BODIHEALTH SYSTEM (K052836)Usa Laser Therapeutics, Inc.2007-02-13
ELECTROPULSE - LOW BACK PAIN (K062532)Pain Relief Technologies2007-02-09
OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 (K063660)Well-Life Healthcare Limited2007-02-07
STAODYN MAX PRESET, MODEL 4470 (K061516)Compex Technologies, Inc.2007-02-06
ZIPPREP ELECTRODE (K070069)Aspect Medical Systems, Inc.2007-02-05
ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM (K061297)The Anspach Effort, Inc.2007-01-26
GEODESIC EEG SYSTEM 300 (K063797)Electrical Geodesics, Incorporated2007-01-25
MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM (K062765)Nuvasive, Inc.2007-01-24
SELECT TENS, MODEL 4600S (K061650)Empi2007-01-22
MODIFICATION TO VECTORVISION TRAUMA (K062358)Brainlab AG2007-01-17
AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T (K062009)Aesculap, Inc.2007-01-17
MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC (K063653)Micrus Endovascular Corporation2007-01-17
DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES (K062996)Axon Systems, Inc.2007-01-12
TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU (K062937)Baylis Medical Co., Inc.2007-01-08
GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES (K062675)Gemore Technology Co, Ltd.2007-01-04
LIFECELL DURAL SUBSTITUTE MATRIX (K061208)Lifecell Corp.2007-01-03
O&P BIVALVE CRANIAL MOLDING HELMET (K063395)Orthotic & Prosthetic Lab, Inc.2006-12-22
BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 (K062533)Neurovirtual USA, Inc.2006-12-22
SUBDERMAL WIRE ELECTRODE, MODEL SWE (K062880)Ives Eeg Solutions, Inc.2006-12-22
SUNSPOTS PRE-GELLED SURFACE ELECTRODES (K062198)Axon Systems, Inc.2006-12-19
PIPELINE II ACCESS SYSTEM (K062814)Depuy Spine, Inc.2006-12-15
STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 (K062640)Stryker Instruments2006-12-14
BIS BILATERAL SENSOR (K062692)Aspect Medical Systems, Inc.2006-12-13
TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS (K063080)Advanced Neuromodulation Systems2006-12-12
VECTORVISION HIP SR (K063028)Brainlab AG2006-12-12
M-BOLUS EMBOLIC MICROSPHERES (K052509)Scion Cardio-Vascular, Inc.2006-12-11
WICK ELECTRODE, MODEL M019260 (K063402)Intelligent Hearing Systems2006-12-11
THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM (K063254)Cordis Neurovascular, Inc.2006-12-07
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