meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
38
Latest Decision
2007-03-07

Clearances · page 30 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K062711 ULTRA LOW PROFILE RONGEUR Baxano, Inc. HAE Class II 2007-03-07
K063408 CTLOGICS NAVIGATIONS SYSTEMS Praxim Medivision, SA HAW Class II 2007-02-28
K062946 TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL Top Corp. GXI Class II 2007-02-15
K052836 BODIHEALTH SYSTEM Usa Laser Therapeutics, Inc. GZJ Class II 2007-02-13
K062532 ELECTROPULSE - LOW BACK PAIN Pain Relief Technologies NUH Class II 2007-02-09
K063660 OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407 Well-Life Healthcare Limited NUH Class II 2007-02-07
K061516 STAODYN MAX PRESET, MODEL 4470 Compex Technologies, Inc. GZJ Class II 2007-02-06
K070069 ZIPPREP ELECTRODE Aspect Medical Systems, Inc. GXY Class II 2007-02-05
K061297 ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM The Anspach Effort, Inc. HBB Class II 2007-01-26
K063797 GEODESIC EEG SYSTEM 300 Electrical Geodesics, Incorporated OLT Class II 2007-01-25
K062765 MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM Nuvasive, Inc. GWF Class II 2007-01-24
K061650 SELECT TENS, MODEL 4600S Empi GZJ Class II 2007-01-22
K063653 MICRUS MICROCOIL SYSTEM, CASHMERE MODEL SRC Micrus Endovascular Corporation HCG Class II 2007-01-17
K062358 MODIFICATION TO VECTORVISION TRAUMA Brainlab AG HAW Class II 2007-01-17
K062009 AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T Aesculap, Inc. JXG Class II 2007-01-17
K062996 DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES Axon Systems, Inc. GXZ Class II 2007-01-12
K062937 TRANSDISCAL SYSTEM, MODELS TDP-17-150-6, TDI-17-150, TDA-PPU-1, TDA-TBK-1, TDX-Y-TSW-TDP, TDX-PMG-PPU Baylis Medical Co., Inc. GXI Class II 2007-01-08
K062675 GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES Gemore Technology Co, Ltd. GXY Class II 2007-01-04
K061208 LIFECELL DURAL SUBSTITUTE MATRIX Lifecell Corp. GXQ Class II 2007-01-03
K063395 O&P BIVALVE CRANIAL MOLDING HELMET Orthotic & Prosthetic Lab, Inc. MVA Class II 2006-12-22
K062533 BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 Neurovirtual USA, Inc. OLT Class II 2006-12-22
K062880 SUBDERMAL WIRE ELECTRODE, MODEL SWE Ives Eeg Solutions, Inc. GXZ Class II 2006-12-22
K062198 SUNSPOTS PRE-GELLED SURFACE ELECTRODES Axon Systems, Inc. GXY Class II 2006-12-19
K062814 PIPELINE II ACCESS SYSTEM Depuy Spine, Inc. GZT Class II 2006-12-15
K062640 STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 Stryker Instruments HAW Class II 2006-12-14
K062692 BIS BILATERAL SENSOR Aspect Medical Systems, Inc. GXY Class II 2006-12-13
K063080 TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS Advanced Neuromodulation Systems GZB Class II 2006-12-12
K063028 VECTORVISION HIP SR Brainlab AG HAW Class II 2006-12-12
K063402 WICK ELECTRODE, MODEL M019260 Intelligent Hearing Systems GXY Class II 2006-12-11
K052509 M-BOLUS EMBOLIC MICROSPHERES Scion Cardio-Vascular, Inc. HCG Class II 2006-12-11
K063254 THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM Cordis Neurovascular, Inc. HCG Class II 2006-12-07
K062819 BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY Bioplate, Inc. GXN Class II 2006-12-04
K062842 TWIST DRILL Walter Lorenz Surgical, Inc. HBE Class II 2006-12-04
K062857 KLS MARTIN QUICK DISC KLS Martin L.P. GXN Class II 2006-11-22
K063467 SMITH & NEPHEW RF CANNULAE Smith & Nephew, Inc. GXI Class II 2006-11-21
K062413 AESCULAP PNEUMATIC KERRISON Aesculap, Inc. HAD Class II 2006-11-21
K062228 ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION Zimmer, Inc. HAW Class II 2006-11-08
K061908 NICOLETONE SYSTEM V32 AMPLIFIER Viasys Neuro Care GWQ Class II 2006-11-06
K063117 MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX Medtronic Neurosurgery GXQ Class II 2006-11-03
K061639 ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON Axon Systems, Inc. GWF Class II 2006-11-01
K062015 CHRONOS VISION EYE TRACKING DEVICE (C-ETD) Chronos Vision GWN Class II 2006-10-31
K062570 PATIENT CONTOURED MESH (PCM) KLS-Martin L.P. GXN Class II 2006-10-31
K061645 MAGPRO, MODEL R30 Tonica Elektronik A/S GWF Class II 2006-10-31
K061725 STRYKER ARIA PNEUMATIC SYSTEM Stryker Instruments HBB Class II 2006-10-26
K061876 CODMAN VPV SYSTEM, MODEL 82-3192 Codman & Shurtleff, Inc. JXG Class II 2006-10-16
K060158 NET-2000 MICROCURRENT STIMULATOR Auri-Stem Medical, Inc. QJQ Class II 2006-10-13
K060669 MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300 Healthonics, Inc. GZJ Class II 2006-10-13
K061362 PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM Plus Orthopedics AG HAW Class II 2006-10-06
K061568 CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 Codman & Shurtleff, Inc. JXG Class II 2006-09-29
K062599 MONITORR ICP EXTERNAL DRAINAGE AND MONITORING SYSTEMS Integra LifeSciences Corporation JXG Class II 2006-09-27
K062758 OWL URF-3AP Diros Technology, Inc. GXD Class II 2006-09-27
K060847 MAGSTIM 200-2 Magstim Company Us, LLC GWF Class II 2006-09-26
K060919 ACTICAL Respironics, Inc. GWK Class II 2006-09-22
K060763 STRYKER INJECTABLE CEMENT Stryker GXP Class II 2006-09-22
K062086 NAVIVISION Brainlab AG HAW Class II 2006-09-20
K060681 MEDTRONIC PS MEDICAL STRATA TYPE VALUE Medtronic Neurosurgery JXG Class II 2006-09-15
K062406 AESCULAP NEURO PATTIES Aesculap, Inc. HBA Class II 2006-09-15
K061224 LAPDOC I Robodent GmbH HAW Class II 2006-09-05
K060397 RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED PAJUNK GmbH Medizintechnologie GXI Class II 2006-08-31
K061248 AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM Medtronic Navigation, Inc. HAW Class II 2006-08-31
K061870 VITALSENSE XHR Respironics, Inc. GWK Class II 2006-08-31
K061799 QUADRATENS, MODEL QT-42 Bio-Research Associates, Inc. GZJ Class II 2006-08-28
K062036 MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4 Micrus Endovascular Corporation HCG Class II 2006-08-25
K062146 UNI KNEE SURGETICS NAVIGATION SYSTEM Praxim S.A HAW Class II 2006-08-21
K060727 VECTORVISION HIP Brainlab AG HAW Class II 2006-08-21
K062041 MODEL 3875 1 X 8 SC TEST STIMULATION LEAD Medtronic, Inc. GZB Class II 2006-08-16
K061166 DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM Biowave Corporation NHI Class II 2006-08-15
K061269 XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES Excel Tech. , Ltd. GXY Class II 2006-08-14
K053348 STRYKER ORTHOPAEDICS RFID INSTRUMENTATION Howmedica Osteonics Corp. HAW Class II 2006-08-04
K060556 BRIGIT SURGICAL DEVICE Zimmer, Inc. HAW Class II 2006-07-31
K060584 NC-STAT Neurometrix, Inc. JXE Class II 2006-07-31
K061640 INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM Integra LifeSciences Corporation GWM Class II 2006-07-27
K061476 ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1 Biomedical Life Systems, Inc. GZJ Class II 2006-07-26
K060973 VYCOR SURGICAL ACCESS SYSTEMS Vycor Medical, LLC GZT Class II 2006-07-26
K060808 BRAINPRO, BRAINPRO ACCESS PAJUNK GmbH Medizintechnologie HAW Class II 2006-07-25
K060952 COLLAGEN NERVE WRAP Collagen Matrix, Inc. JXI Class II 2006-07-14
K061791 FOCUS VNG/ENG TYPE 1068 Gn Otometrics A/S GWN Class II 2006-07-11
K061135 MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019 Aesculap GWG Class II 2006-07-11
K053468 NESS L300 Ness-Neuromuscular Electrical Stimulation Systems GZI Class II 2006-07-07
K061487 DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE Collagen Matrix, Inc. GXQ Class II 2006-06-26
K060900 SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 Spacelabs Medical, Inc. OLW Class II 2006-06-23
K061443 SMART USBLITE, MODEL M011120 Intelligent Hearing Systems GWJ Class II 2006-06-23
K052711 EMJOI TENS DEVICE Emjoi, Inc. GZJ Class II 2006-06-23
K060508 POINTER PLUS Lhasa Oms, Inc. GZJ Class II 2006-06-19
K060517 POINTER EXCEL Lhasa Oms, Inc. GZJ Class II 2006-06-19
K060997 SNAP II EEG MONITOR Everest Biomedical Instruments Co. OLW Class II 2006-06-15
K053159 VECTORVISION SPINE Brainlab AG HAW Class II 2006-06-06
K061343 INSPIRSTAR GLOVE ELECTRODE Inspirstar, Inc. GXY Class II 2006-05-31
K060189 PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE) Ives Eeg Solutions, Inc. GXZ Class II 2006-05-30
K053363 DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES Ad-Tech Medical Instrument Corp GYC Class II 2006-05-30
K060374 REFA, PHYSIOLOGICAL AMPLIFIER Tms International BV GWL Class II 2006-05-30
K053358 DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES Ad-Tech Medical Instrument Corp GZL Class II 2006-05-25
K061113 ORTHOMON Axon Systems, Inc. GWF Class II 2006-05-23
K053244 LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT Integra Lifesciences Corp. GWM Class II 2006-05-10
K060975 IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2 Theratech, Inc. LIH Class II 2006-05-10
K061148 RHYTHMLINK DISC ELECTRODES Rhythmlink International, LLC GXY Class II 2006-05-10
K060246 INFREX Johari Digital Healthcare , Ltd. GZJ Class II 2006-05-05
K060803 G.USBAMP G.Tec Medical Engineering GmbH GWL Class II 2006-05-02
K060799 COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA Cosman Medical, Inc. GXI Class II 2006-05-02
K060554 CMA CEREBRAL TISSUE MONITORING SYSTEM Cma Microdialysis AB GWM Class II 2006-05-02

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