meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
33
Latest Decision
2003-05-14

Clearances · page 35 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K031168 MATRIX STRETCH RESISTANT DETACHABLE COIL Boston Scientific, Target HCG Class II 2003-05-14
K023424 IGI-SYSTEM Denx Advanced Dental Systems HAW Class II 2003-05-09
K031156 NAVITRACK SYSTEM-FLUOROSPINE, MODEL 900.005 Orthosoft, Inc. HAW Class II 2003-05-09
K031008 AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) Aesculap HBA Class II 2003-05-09
K030907 STACKED ABR FOR NAVIGATOR PRO Bio-Logic Systems Corp. GWJ Class II 2003-05-09
K030375 SOFT-TOUCH TENS ELECTRODE Pain Management Technologies GXY Class II 2003-05-05
K011399 BIOMET CRANIOFACIAL ACRYLIC CEMENT Biomet, Inc. GXP Class II 2003-05-05
K030489 BRM2 BRAIN MONITOR Brainz Instruments , Ltd. OLT Class II 2003-05-02
K021952 HIVOX DREAMATE DM-800 Hivox Biotek, Inc. GZJ Class II 2003-05-02
K030343 DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE Gyrus Ent LLC HAW Class II 2003-05-02
K031202 MEDIPALM-20 Braebon Medical Corp. OLV Class II 2003-05-01
K031009 MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM Bio-Logic Systems Corp. GWJ Class II 2003-04-28
K030297 FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 Enraf-Nonius, B.V. GXY Class II 2003-04-28
K030461 A127 LEAD EXTENSION Advanced Neuromodulation Systems GZB Class II 2003-04-24
K030764 Z-BOX Z-Kat, Inc. HAW Class II 2003-04-24
K022417 CARE STIM Care Rehab and Orthopaedic GZJ Class II 2003-04-10
K030823 ALGO 3I NEWBORN HEARING SCREENER Natus Medical, Inc. GWJ Class II 2003-04-09
K023231 ELFCARE DEVICE, MODELS 314A THROUGH 314G Mediseb , Ltd. GZJ Class II 2003-04-04
K030172 SMALL HIGH SPEED MOTOR DRILL SYSTEM Brasseler USA I, L.P. HBE Class II 2003-04-03
K022277 OSTEOMED CRANIAL FLAP FIXATION SYSTEM Osteomed Corp. GXN Class II 2003-04-01
K030674 MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD Advanced Neuromodulation Systems GZB Class II 2003-03-28
K024349 AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER Aesculap, Inc. HCH Class II 2003-03-24
K022198 ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 Richard Wolf Medical Instruments Corp. GWG Class II 2003-03-21
K030537 DIGI-PRO TENS/WL-2203B,2204B,2204B-P1,2204B-P2,2205B Well-Life Healthcare, Inc. GZJ Class II 2003-03-20
K030698 AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV Aesculap, Inc. JXG Class II 2003-03-20
K030378 STRYKER LEIBINGER CRANIAL FIXATION SYSTEM Stryker Instruments GXN Class II 2003-03-20
K030552 IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM Medtronic Surgical Navigation Technologies HAW Class II 2003-03-19
K023472 LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812 Class A Enterprises, Inc. GXZ Class II 2003-03-18
K030140 DUOMED, SERIES 500, (MODELS ID 500, FL 500) Duomed, Inc. GZJ Class II 2003-03-18
K030475 GDC STRETCH RESISTANT DETACHABLE COIL Boston Scientific, Target HCG Class II 2003-03-14
K024201 NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000 Image-Guided Neurologics, Inc. HAW Class II 2003-03-12
K030118 RAPID PROGRAMMAR Advanced Neuromodulation Systems GZB Class II 2003-03-11
K023445 TRACERS BONE CEMENT OPACIFIER Parallax Medical, Inc. MYU Class II 2003-03-11
K022917 HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES Home Care Technology Co., Ltd. GXY Class II 2003-03-04
K021537 MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005 Vermont Medical, Inc. GXY Class II 2003-03-03
K030289 HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N Integra Lifesciences Corp. JXG Class II 2003-02-26
K024100 IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND Theratech, Inc. LIH Class II 2003-02-25
K023949 NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES Image-Guided Neurologics, Inc. HAW Class II 2003-02-25
K023959 JEROME GLASS RING The Jerome Group, Inc. HAX Class II 2003-02-21
K030106 STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE Medtronic Surgical Navigation Technologies HAW Class II 2003-02-12
K023868 DAN KERRISON RONGEURS, MODELS K1 + BILLY 1 Dannoritzer Medical Instruments HAE Class II 2003-02-07
K023771 SYNAMPS2 Neuroscan GWQ Class II 2003-02-06
K021271 ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3 Biomedical Life Systems GZJ Class II 2003-02-06
K021270 ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2 Biomedical Life Systems GZJ Class II 2003-02-06
K022364 NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200 Orthosoft, Inc. HAW Class II 2003-02-04
K024101 PHOENIX UNIVERSAL SHUNT SYSTEM Phoenix Biomedical Corp. JXG Class II 2003-01-27
K024040 ACCURA ELITE SHUNT SYSTEM Phoenix Biomedical Corp. JXG Class II 2003-01-27
K022433 NEOGENESYS 2K Sanexas Intl. GmbH LIH Class II 2003-01-24
K022365 STRYKER NAVIGATION SYSTEM - HIP MODULE Stryker Instruments HAW Class II 2003-01-22
K023575 CONCERT CRANIOPLAST Immedica, Inc. GXP Class II 2003-01-22
K023536 NUAMPS Neuroscan OLT Class II 2003-01-15
K023459 DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES Datex-Ohmeda OLW Class II 2003-01-13
K021794 TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING) TMD-26AY TATUNG TENS (YELLOW HOUSING) Tatung Co. GZJ Class II 2003-01-13
K023443 MEDS-3 NEUROMUSCULAR STIMULATOR Medical Equipment Device Specialists GZJ Class II 2003-01-13
K023572 LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET Rehabilitation Institute,Loma Linda University Med MVA Class II 2003-01-13
K023435 MEDS-4 NEUROMUSCULAR STIMULATOR Medical Equipment Device Specialists GZJ Class II 2003-01-13
K022126 CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM Medtronic Surgical Navigation Technologies HAW Class II 2003-01-03
K022249 NIGHTRON POLYSOMNOGRAPHY SYSTEM Telediagnostic Systems, Inc. OLV Class II 2002-12-31
K020020 THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302) Well-Life Healthcare, Inc. GZJ Class II 2002-12-30
K022914 RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES Rhythmlink International, LLC GXZ Class II 2002-12-20
K023975 VOYAGER LINUX Z-Kat, Inc. HAW Class II 2002-12-20
K023089 GELSPHERES EMBOLIC AGENT Biocure, Inc. HCG Class II 2002-12-16
K023212 AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS Ag Garments GXY Class II 2002-12-13
K021798 SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS Smith & Nephew, Inc. HAW Class II 2002-12-09
K023718 QUICKSET MIMIX BONE VOID FILLER Walter Lorenz Surgical, Inc. GXP Class II 2002-12-04
K022494 HOME CARE JELLY Roc Chinese-European Industrial Research Society GYB Class II 2002-12-02
K021430 SANIDAD TENS-DUO MODE GP8016N Rolor Electronics Corp. GZJ Class II 2002-12-02
K023066 DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) Sodemsystems HBB Class II 2002-11-25
K021846 804SIII; 804W; LIBRA TENS; 410; S-TENS II Body Clock Health Care, Ltd. GZJ Class II 2002-11-22
K022986 THE BIOPLATE BATTERY POWERED DRILL Bioplate, Inc. HBC Class II 2002-11-19
K022841 ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9 Biomedical Life Systems, Inc. GZJ Class II 2002-11-19
K022925 ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10 Biomedical Life Systems, Inc. GZJ Class II 2002-11-19
K021980 HIP MODULE FOR THE STEALTHSTATION SYSTEM Medtronic Surgical Navigation Technologies HAW Class II 2002-11-19
K022731 V TENS PLUS Body Clock Health Care, Ltd. GZJ Class II 2002-11-14
K022712 HAND DRILL, MODEL 11-9901-7 Medical Design, LLC HBG Class II 2002-11-12
K021477 PRECLUDE MVP DURA SUBSTITUTE W. L. Gore & Associates, Inc. GXQ Class II 2002-11-08
K020749 DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS Everyway Medical Instruments Co.,Ltd GZJ Class II 2002-10-31
K022638 NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT Neurorecovery, Inc. GWM Class II 2002-10-31
K021306 VECTORVISION CT-FREE KNEE Brainlab AG HAW Class II 2002-10-25
K020285 CMA CEREBRAL TISSUE MONITORING SYSTEM Cma Microdialysis AB GWM Class II 2002-10-23
K022420 MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01 Micrus Corp. HCG Class II 2002-10-22
K022942 CRANIOCUT Aesculap, Inc. HBE Class II 2002-10-21
K022907 ANSPACH POWERED KERRISON SYSTEM (PKS) The Anspach Effort, Inc. HAD Class II 2002-10-21
K022370 FRAMELOCK; FRAMELOCK ACCESSORIES Medtronic Xomed, Inc. HBG Class II 2002-10-18
K021815 SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS Smith & Nephew, Inc. HAW Class II 2002-10-17
K022785 EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION Axon Systems, Inc. GWQ Class II 2002-10-09
K020507 OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 Olympus Winter & Ibe GmbH GWG Class II 2002-10-08
K020670 MODEL 4310 PSARRAY2 EEG ELECTRODE Physiometrix, Inc. GXY Class II 2002-10-08
K020671 PSA4000 EEG MONITOR WITH FRONTAL PSI Physiometrix, Inc. OLW Class II 2002-10-04
K020903 DOCXS B SERIES ELECTRODES Docxs, LLC GXY Class II 2002-09-26
K022100 NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 Image-Guided Neurologics, Inc. HAW Class II 2002-09-25
K020712 ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4 Biomedical Life Systems, Inc. GZJ Class II 2002-09-24
K022076 FIRST CHOICE & FIRST CHOICE PLUS Body Clock Health Care, Ltd. GZJ Class II 2002-09-24
K022006 CONDUCTIVE GEL The Dezac Group GYB Class II 2002-09-13
K021942 RADIONICS POLE NEEDLES Radionics, A Division of Tyco Healthcare Group LP GXI Class II 2002-09-11
K022241 VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX Vertis Neuroscience, Inc. NHI Class II 2002-09-11
K021485 BIOSOMNIA Oxford Biosignals Limited OMC Class II 2002-09-11
K022037 XLTEK SLEEP SYSTEM Excel Tech. , Ltd. OLV Class II 2002-09-10
K020631 IPLAN Brainlab AG HAW Class II 2002-09-09
K022273 CRANIAL SYMMETRY SYSTEM Beverly Hills Prosthetics Orthotics, Inc. MVA Class II 2002-09-09

6,130 clearances in the Neurology panel. Data: openFDA.