meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
41
Latest Decision
2008-11-20

Clearances · page 28 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K083076 STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836 Medtronic Neurosurgery JXG Class II 2008-11-20
K080771 TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC Top Corp. GXI Class II 2008-11-10
K081773 OSV II Integra Neurosciences Implants S.A. JXG Class II 2008-11-06
K080217 COMPONENT NEUROMONITORING SYSTEM Moberg Research, Inc. OMA Class II 2008-11-05
K082945 STARLIGHT Orthomerica Products, Inc. OAN Class II 2008-10-31
K081741 NEUROLINK IP, MODEL PK1113 Excel-Tech Ltd. (Xltek) GWQ Class II 2008-10-31
K082267 PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1 Smith & Nephew, Inc. HAW Class II 2008-10-29
K082514 TENS/EMS COMBO, EMS, TENS Medihightec Medical Co., Ltd. GZJ Class II 2008-10-21
K082739 MICRUS MICROCOIL DELIVERY SYSTEM Micrus Endovascular Corporation HCG Class II 2008-10-17
K081475 ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] Medtronic Xomed, Inc. HBE Class II 2008-10-17
K082051 COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 Cosman Medical, Inc. GXD Class II 2008-10-16
K082012 COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN Cosman Medical, Inc. GXI Class II 2008-10-14
K082250 AURAGEN CORTICAL SURFACE ELECTRODES Integra Neurosciences GYC Class II 2008-10-10
K081401 MAYFIELD MR/X-RAY SKULL CLAMP Integra Lifesciences Corp. HBL Class II 2008-10-08
DEN070003 NEUROSTAR TMS SYSTEM Neuronetics OBP Class II 2008-10-07
K071969 SEN-4100 ELECTRIC STIMULATOR Nihon Kohden America, Inc. GWF Class II 2008-10-06
K082461 BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B MicroVention, Inc. HCG Class II 2008-10-02
K081871 UNIVERSAL ELECTRODES Neurometrix, Inc. GXY Class II 2008-09-29
K081489 L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS Peter Lazic GmbH HCH Class II 2008-09-25
K081994 STARLIGHT Orthomerica Products, Inc. OAN Class II 2008-09-12
K082324 TRUFILL DCS SYRINGE Cordis Neurovascular, Inc. HCG Class II 2008-09-12
K080221 EA STIMULATOR Helio Medical Supplies, Inc. GZJ Class II 2008-09-09
K081151 COMPUMEDICS NEUVO Compumedics USA, Ltd. GWQ Class II 2008-09-08
K073615 BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED Brainlab AG HAW Class II 2008-09-05
K070250 NUTRITONE FACIAL BEAUTY SYSTEM Isomers Laboratories, Inc. NFO Class II 2008-09-04
K081141 COMBOCARE 2000 Xanacare Technologies, LLC GZJ Class II 2008-08-29
K080546 NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A Nihon Kohden America, Inc. OLT Class II 2008-08-29
K082127 STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 Medtronic Neurosurgery JXG Class II 2008-08-27
K082175 MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION Bioplate, Inc. GXN Class II 2008-08-13
K081942 NEUROCATH AG Vygon Neuro JXG Class II 2008-08-12
K081651 INSTRUMED RONGEUR Instrumed International, Inc. HAE Class II 2008-08-08
K081729 MODIFICATION TO GFX NERVE ABLATION SYSTEM Bioform Medical, Inc. GXD Class II 2008-08-07
K072629 DIGIMATCH ROBODOC SURGICAL SYSTEM Integrated Surgical Systems, Inc. OJP Class II 2008-08-06
K081232 TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES Praxim HAW Class II 2008-08-06
K080298 DERMABIOSAFE Complete Product Resources GXY Class II 2008-08-05
K080276 SELF-ADHESIVE ELECTRODES Cathay Health Care Equipment Manufacturing, Inc. GXY Class II 2008-08-04
K073386 JOINT STIM, MODEL 1000 Pain Management Technologies NYN Class II 2008-07-30
K081430 ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING Elekta Neuromag OY OLX Class II 2008-07-28
K081208 CINCH ANCHOR, MODEL 1194 Advanced Neuromodulation Systems GZB Class II 2008-07-18
K080875 PIGALILEO 4TH GENERATION SYSTEM Smith & Nephew, Inc. HAW Class II 2008-07-18
K080450 STRYKER POWER TOOL NAVIGATOR ATTACHMENT Stryker Corp. HAW Class II 2008-07-17
K080666 HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS MicroVention, Inc. HCG Class II 2008-07-11
K071446 ELECTRODE ARRAY CAP Electrode Arrays GXY Class II 2008-07-02
K080379 MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT Micrus Endovascular Corporation HCG Class II 2008-06-30
K071984 MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM Cma Microdialysis AB GWM Class II 2008-06-27
K080304 PRO TENS, MODEL WL-240 RX Well-Life Healthcare Limited GZJ Class II 2008-06-20
K080902 FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058 Lorenz Biotech S.P.A. GXY Class II 2008-06-13
K073229 NERVE MONITORING CABLE Pioneer Surgical Technology GXZ Class II 2008-06-06
K080678 UNI-KNEE 2.0 Brainlab AG HAW Class II 2008-06-06
K080386 COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE Columbia Scientific Development, LLC GXY Class II 2008-05-30
K081102 VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM Visionsense, Ltd. GWG Class II 2008-05-29
K073006 OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM Takiron Co., Ltd. GWO Class II 2008-05-29
K073467 SPINEASSIST SYSTEM Mazor Surgical Technologies , Ltd. HAW Class II 2008-05-23
K080547 ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 Aesculap Implant System, Inc. HAW Class II 2008-05-23
K070412 ELEXOMA MEDIC Redplane AG QJQ Class II 2008-05-21
K080168 SHUNTCHECK - CSF SHUNT FLOW DETECTOR Neuro Diagnostic Devices JXG Class II 2008-05-16
K072276 SUBDERMAL NEEDLE ELECTRODES Xian Friendship Electronics Co., Ltd. GXZ Class II 2008-05-16
K080250 LEKSELL SURGIPLAN, MODEL 1006947 Elekta Instrument AB HAW Class II 2008-05-13
K072410 KSEA CLEARVISION II, MODEL 40334120 KARL STORZ Endoscopy-America, Inc. GWG Class II 2008-05-09
K080437 MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF Micrus Endovascular Corporation HCG Class II 2008-05-08
K080967 TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT Cordis Neurovascular, Inc. HCG Class II 2008-05-02
K073532 DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES Technomed Europe GXY Class II 2008-05-01
K080802 EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL The Anspach Effort, Inc. HBE Class II 2008-04-30
K072379 MPS OXIPORT AND MPS OXIPORT PLUS Innerspace, Inc. GWM Class II 2008-04-29
K070109 NEUROMETRIX ADVANCE Neurometrix, Inc. JXE Class II 2008-04-25
K072799 TARGET STERILE ELECTRODE Vision Quest Industries, Inc. GXY Class II 2008-04-24
K070217 INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE Neuro Resource Group, Inc. NFO Class II 2008-04-04
K080060 VIVOSONIC NEUROSCREEN Vivosonic, Inc. GWJ Class II 2008-04-04
K080444 CONMED LINVATEC OSPREY DRILL SYSTEM Conmed Linvatec HBC Class II 2008-04-02
K061907 MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES GE Healthcare OLW Class II 2008-03-27
K071120 AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999 Aemed, Inc. GZJ Class II 2008-03-13
K073008 KFH ENERGY, MODEL: E1 Kingfisher Healthcare NV GZJ Class II 2008-03-11
K071869 TENS/IF 14 Emsi GZJ Class II 2008-03-07
K080494 BAXANO ULTRA LOW PROFILE RONGEUR Baxano, Inc. HAE Class II 2008-03-04
K073557 EEG NEUROAMP, MODEL CS10137 Corscience GmbH & Co. KG HCC Class II 2008-02-28
K073384 SMART COUPLER, MODEL M015401 Intelligent Hearing Systems GWJ Class II 2008-02-28
K073163 LIMITED ARTIFACT SKULL PIN, MODEL 0107 Dinkler Surgical Devices, Inc. HBL Class II 2008-02-28
K080219 MODIFICATION TO:NESS L300 Ness-Neuromuscular Electrical Stimulation Systems GZI Class II 2008-02-28
K073442 MICRUS MICROCOIL SYSTEMS Micrus Endovascular Corporation HCG Class II 2008-02-26
K073576 NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES Harod Enterprises, Inc. HBA Class II 2008-02-22
K072382 MODEL I-2000 MONITOR Infinite Biomedical Technologies OLT Class II 2008-02-15
K073419 PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES Rj Medical, Inc. HCG Class II 2008-02-14
K073438 PROSTIM 1000/2000 Bio Protech, Inc. GZJ Class II 2008-02-07
K072899 ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 Aesculap Implant Systems, Inc. HAW Class II 2008-02-06
K073626 BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM Bio-Logic Systems Corp. GWJ Class II 2008-02-05
K072254 VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM Interacoustics A/S GWN Class II 2008-02-05
K071866 NTRAINER SYSTEM Kcbiomedix, Inc. HCC Class II 2008-02-01
K072123 HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE Biowave Corporation GZJ Class II 2008-02-01
K073139 SMALL LUMEN PERITONEAL CATHETER Medtronic Neurosurgery JXG Class II 2008-01-30
K073665 ALGO 5 NEWBORN HEARING SCREENER Natus Medical, Inc. GWJ Class II 2008-01-25
K072806 MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) Mako Surgical Corp. HAW Class II 2008-01-24
K072862 BOSTON-BAND CRANIAL REMODLING ORTHOSIS Boston Brace Intl., Inc. OAN Class II 2008-01-22
K073491 EEG-1100A SWITCH BOX Nihon Kohden America, Inc. OLV Class II 2008-01-11
K071782 MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES Micromed S.P.A. OLV Class II 2008-01-10
K072566 HANGER CRANIAL BAND Hanger Prosthetics & Orthotics, Inc. OAN Class II 2008-01-09
K073336 CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 Codman & Shurtleff, Inc. HBF Class II 2008-01-04
K073237 REHASTIM & REHAMOVE Hasomed GmbH GZI Class II 2007-12-27
K070012 POLYBONE Kyung Won Medical Co., Ltd. GXP Class II 2007-12-27
K062580 GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) GE Healthcare GXY Class II 2007-12-21
K071063 LINASYS Pathfinder Therapeutics, Inc. OEW Class II 2007-12-20

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