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Neurology

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

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RecordFirmDate
RAPID PROGRAMMAR (K030118)Advanced Neuromodulation Systems2003-03-11
TRACERS BONE CEMENT OPACIFIER (K023445)Parallax Medical, Inc.2003-03-11
HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES (K022917)Home Care Technology Co., Ltd.2003-03-04
MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005 (K021537)Vermont Medical, Inc.2003-03-03
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N (K030289)Integra Lifesciences Corp.2003-02-26
NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES (K023949)Image-Guided Neurologics, Inc.2003-02-25
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND (K024100)Theratech, Inc.2003-02-25
JEROME GLASS RING (K023959)The Jerome Group, Inc.2003-02-21
STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE (K030106)Medtronic Surgical Navigation Technologies2003-02-12
DAN KERRISON RONGEURS, MODELS K1 + BILLY 1 (K023868)Dannoritzer Medical Instruments2003-02-07
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3 (K021271)Biomedical Life Systems2003-02-06
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2 (K021270)Biomedical Life Systems2003-02-06
SYNAMPS2 (K023771)Neuroscan2003-02-06
NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200 (K022364)Orthosoft, Inc.2003-02-04
PHOENIX UNIVERSAL SHUNT SYSTEM (K024101)Phoenix Biomedical Corp.2003-01-27
ACCURA ELITE SHUNT SYSTEM (K024040)Phoenix Biomedical Corp.2003-01-27
NEOGENESYS 2K (K022433)Sanexas Intl. GmbH2003-01-24
STRYKER NAVIGATION SYSTEM - HIP MODULE (K022365)Stryker Instruments2003-01-22
CONCERT CRANIOPLAST (K023575)Immedica, Inc.2003-01-22
NUAMPS (K023536)Neuroscan2003-01-15
LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET (K023572)Rehabilitation Institute,Loma Linda University Med2003-01-13
DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES (K023459)Datex-Ohmeda2003-01-13
TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING) TMD-26AY TATUNG TENS (YELLOW HOUSING) (K021794)Tatung Co.2003-01-13
MEDS-3 NEUROMUSCULAR STIMULATOR (K023443)Medical Equipment Device Specialists2003-01-13
MEDS-4 NEUROMUSCULAR STIMULATOR (K023435)Medical Equipment Device Specialists2003-01-13
CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM (K022126)Medtronic Surgical Navigation Technologies2003-01-03
NIGHTRON POLYSOMNOGRAPHY SYSTEM (K022249)Telediagnostic Systems, Inc.2002-12-31
THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302) (K020020)Well-Life Healthcare, Inc.2002-12-30
VOYAGER LINUX (K023975)Z-Kat, Inc.2002-12-20
RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES (K022914)Rhythmlink International, LLC2002-12-20
GELSPHERES EMBOLIC AGENT (K023089)Biocure, Inc.2002-12-16
AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS (K023212)Ag Garments2002-12-13
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS (K021798)Smith & Nephew, Inc.2002-12-09
QUICKSET MIMIX BONE VOID FILLER (K023718)Walter Lorenz Surgical, Inc.2002-12-04
HOME CARE JELLY (K022494)Roc Chinese-European Industrial Research Society2002-12-02
SANIDAD TENS-DUO MODE GP8016N (K021430)Rolor Electronics Corp.2002-12-02
DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) (K023066)Sodemsystems2002-11-25
804SIII; 804W; LIBRA TENS; 410; S-TENS II (K021846)Body Clock Health Care, Ltd.2002-11-22
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9 (K022841)Biomedical Life Systems, Inc.2002-11-19
HIP MODULE FOR THE STEALTHSTATION SYSTEM (K021980)Medtronic Surgical Navigation Technologies2002-11-19
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10 (K022925)Biomedical Life Systems, Inc.2002-11-19
THE BIOPLATE BATTERY POWERED DRILL (K022986)Bioplate, Inc.2002-11-19
V TENS PLUS (K022731)Body Clock Health Care, Ltd.2002-11-14
HAND DRILL, MODEL 11-9901-7 (K022712)Medical Design, LLC2002-11-12
PRECLUDE MVP DURA SUBSTITUTE (K021477)W. L. Gore & Associates, Inc.2002-11-08
DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS (K020749)Everyway Medical Instruments Co.,Ltd2002-10-31
NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT (K022638)Neurorecovery, Inc.2002-10-31
VECTORVISION CT-FREE KNEE (K021306)Brainlab AG2002-10-25
CMA CEREBRAL TISSUE MONITORING SYSTEM (K020285)Cma Microdialysis AB2002-10-23
MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01 (K022420)Micrus Corp.2002-10-22
CRANIOCUT (K022942)Aesculap, Inc.2002-10-21
ANSPACH POWERED KERRISON SYSTEM (PKS) (K022907)The Anspach Effort, Inc.2002-10-21
FRAMELOCK; FRAMELOCK ACCESSORIES (K022370)Medtronic Xomed, Inc.2002-10-18
SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS (K021815)Smith & Nephew, Inc.2002-10-17
EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION (K022785)Axon Systems, Inc.2002-10-09
OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 (K020507)Olympus Winter & Ibe GmbH2002-10-08
MODEL 4310 PSARRAY2 EEG ELECTRODE (K020670)Physiometrix, Inc.2002-10-08
PSA4000 EEG MONITOR WITH FRONTAL PSI (K020671)Physiometrix, Inc.2002-10-04
DOCXS B SERIES ELECTRODES (K020903)Docxs, LLC2002-09-26
NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 (K022100)Image-Guided Neurologics, Inc.2002-09-25
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4 (K020712)Biomedical Life Systems, Inc.2002-09-24
FIRST CHOICE & FIRST CHOICE PLUS (K022076)Body Clock Health Care, Ltd.2002-09-24
CONDUCTIVE GEL (K022006)The Dezac Group2002-09-13
RADIONICS POLE NEEDLES (K021942)Radionics, A Division of Tyco Healthcare Group LP2002-09-11
BIOSOMNIA (K021485)Oxford Biosignals Limited2002-09-11
VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX (K022241)Vertis Neuroscience, Inc.2002-09-11
XLTEK SLEEP SYSTEM (K022037)Excel Tech. , Ltd.2002-09-10
IPLAN (K020631)Brainlab AG2002-09-09
ACT III VENTRICULAR CATHETER (K013705)Innerspace, Inc.2002-09-09
CRANIAL SYMMETRY SYSTEM (K022273)Beverly Hills Prosthetics Orthotics, Inc.2002-09-09
MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT (K022735)MicroVention, Inc.2002-09-06
ABR-2000 (K020360)Meridian Co., Ltd.2002-08-29
GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM (K021807)Grass Instrument Co.2002-08-29
NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120 (K021760)Orthosoft, Inc.2002-08-27
DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR (K020400)Meps, LLC2002-08-23
BRAINET (K021986)Nicolet Biomedical, Inc.2002-08-23
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM (K022554)Integra Neurosciences2002-08-23
ULTRASTIM KIT (K013532)Axelgaard Mfg. Co., Ltd.2002-08-22
CONTOUR SE MICROSPHERES (K022427)Boston Scientific Corp2002-08-22
CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L (K022553)Integra Neurosciences2002-08-20
MSS-28CS-301/701 NEEDLESCOPE (K013759)Olympus Optical Co., Ltd.2002-08-20
SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS (K022460)Smith & Nephew, Inc.2002-08-19
STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE (K022414)Medtronic Surgical Navigation Technologies2002-08-14
SPHERZ (K022074)I.Z.I. Corp.2002-08-13
96 CHANNEL EEG HEADBOX MODEL EMU96 (K021599)Excel Tech. , Ltd.2002-08-13
SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY (K022197)The Electrode Store, Inc.2002-08-13
MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC (K022405)Rehabilicare, Inc.2002-08-12
LAMITRODE S-SERIES (S4 AND S8) LEADS (K022222)Advanced Neuromodulation System,Inc2002-08-08
ALPHA DRIVE SYSTEM (K013396)Alpha Omega , Ltd.2002-08-07
PERF (OMMAYA STYLE) RESERVOIRS (K021644)Phoenix Biomedical Corp.2002-08-06
BRESAGEN CATHETER, MODEL CS-3000 (K021481)Bresagen, Inc.2002-08-06
HMS-DHR-3 NEUROMUSCULAR STIMULATOR (K021496)Home Medical Services2002-08-06
BONESOURCE HAC (K021440)Stryker Instruments2002-08-02
PANAG (K011891)Panag International2002-07-30
TTECH MODEL 200E + TENS DEVICE (K021436)Theratech, Inc.2002-07-30
RESORBABLE CRANIAL CLAMPS (K021408)Synthes (Usa)2002-07-29
PSG INPUT BOX, MODEL JE-912AK (K022121)Nihon Kohden America, Inc.2002-07-29
MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 (K021604)Ohio Medical Instrument Co., Inc.2002-07-29
MICROPLEX COIL SYSTEM (MCS) (K020434)MicroVention, Inc.2002-07-29
CODMAN BACTISEAL EVD CATHETER SET (K021653)Codman & Shurtleff, Inc.2002-07-29
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