meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
36
Latest Decision
2006-04-28

Clearances · page 31 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K060222 LOW BACK PAIN RELIEF SYSTEM /MODELS GM310PP,GM320PP,GM321PP, AND GM330PP Gemore Technology Co, Ltd. NUH Class II 2006-04-28
K060336 NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 Orthosoft, Inc. HAW Class II 2006-04-28
K053415 LESIONPOINT RF CANNULA Cosman Medical, Inc. GXI Class II 2006-04-25
K053386 XLTEK EMU40 EEG HEADBOX, MODEL PK1072 Excel Tech. , Ltd. GWQ Class II 2006-04-21
K060625 NEXUS DETACHABLE COIL SYSTEM, MORPHEUS 3D CSR Micro Therapeutics, Inc. HCG Class II 2006-04-20
K060443 NORIAN CRS FAST SET PUTTY Synthes (Usa) GXP Class II 2006-04-13
K060445 NORIAN CRS BONE CEMENT Synthes (Usa) GXP Class II 2006-04-13
K052527 NEUROPROBES Alpha Omega Engineering , Ltd. GZL Class II 2006-04-12
K060282 TOTAL KNEE SURGETICS NAVIGATION SYSTEM Praxim S.A HAW Class II 2006-04-10
K053542 SURGETICS ORTHO OSTEOLOGICS NAVIGATION SYSTEM Praxim S.A HAW Class II 2006-04-10
K060260 MICROPOWER HAND PIECE HIGH SPEED DRILL Linvatec Corp. HBC Class II 2006-04-10
K050989 AWQ-104 Lhasa Oms, Inc. GZJ Class II 2006-04-06
K053626 INTERX500 FLEXIBLE ARRAY ELECTRODE Neuro Resource Group, Inc. GXY Class II 2006-03-29
K060523 NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM Cyberkinetics, Inc. OMC Class II 2006-03-28
K053164 IPLAN FLOW Brainlab AG HAW Class II 2006-03-23
K060121 BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS Biomet Manufacturing Corp HAW Class II 2006-03-21
K060468 VECTORVISION HIP Brainlab AG HAW Class II 2006-03-20
K051093 OSTEOPORE PCL SCAFFOLD Osteopore, Inc. GXP Class II 2006-03-17
K052785 OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406 Well-Life Healthcare Limited NUH Class II 2006-03-17
K060368 INSPIRSTAR IS02 MICROCURRENT STIMULATOR Inspirstar, Inc. GZJ Class II 2006-03-14
K051128 ELECTROPULSE Pain Relief Technologies GZJ Class II 2006-03-10
K060032 RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053 Restorative Therapies, Inc. GZI Class II 2006-03-10
K053284 MAGBODY DT-600 Durtech System Corp. GZJ Class II 2006-03-10
K052623 IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM Medtronic Navigation, Inc. HAW Class II 2006-03-02
K060097 GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00 KLS-Martin L.P. GZT Class II 2006-02-27
K051020 ES-160 Lhasa Oms, Inc. GZJ Class II 2006-02-24
K052966 CI KNEE, CI MI TKR Brainlab AG HAW Class II 2006-02-13
K053127 IPLAN Brainlab AG HAW Class II 2006-02-09
K053058 XLTEK NEUROPATH, MODEL PK1070 Excel Tech. , Ltd. JXE Class II 2006-02-07
K053548 MODIFIED PVA-PLUS FOAM EMBOLIZATION PARTICLES AND MAXISTAT AND MICROSTAT PVA FOAM EMBOLIZATION PARTICLES Protein Polymer Technologies, Inc. HCG Class II 2006-01-30
K052813 FD TENS 2030, MODEL DFJ24T Fuji Dynamics Limited GZJ Class II 2006-01-25
K053606 BE PLUS / AURA-LTM64 AMPLIFIER Eb Neuro S.P.A. GWL Class II 2006-01-24
K052878 NT-1000 Neuro Therm, Inc. GXD Class II 2006-01-23
K053350 MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS Codman & Shurtleff, Inc. JXG Class II 2006-01-19
K052357 PATHWAY - ATS/CHEPS Medoc Ltd. Advanced Medical Systems NTU Class II 2006-01-19
K053107 CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD Codman & Shurtleff, Inc. JXG Class II 2006-01-19
K053526 MICROSPEED UNI MOTOR SYSTEM Aesculap, Inc. HBC Class II 2006-01-18
K053004 MSAS-VANTAGE Biomeridian, Int. GZO Class II 2006-01-13
K052425 ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION Zimmer, Inc. HAW Class II 2005-12-28
K052875 PROSTIM REUSABLE NEUROSTIMULATION ELECTRODES Summit Manufacturing, LLC GXY Class II 2005-12-27
K051864 MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 The Magstim Company , Ltd. GWF Class II 2005-12-21
K053214 THERAKNIT GARMENT ELECTRODE Neurotron Medical GXY Class II 2005-12-20
K052840 IGI-SYSTEM Denx Advanced Dental Systems HAW Class II 2005-12-16
K052871 STRYKER CUSTOM TI IMPLANT Stryker Leibinger GXN Class II 2005-12-16
K052386 MEDTRONIC M2 MAGNET ADJUSTMENT TOOL Medtronic Neurosurgery JXG Class II 2005-12-16
K053197 TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION Cordis Neurovascular, Inc. HCG Class II 2005-12-15
K053250 ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT Advanced Neuromodulation Systems GZB Class II 2005-12-15
K053199 SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT Synthes (Usa) GXN Class II 2005-12-14
K052289 DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE Biowave Corporation LIH Class II 2005-12-13
K053160 MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE Micrus Endovascular Corporation HCG Class II 2005-12-07
K052625 BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 Bionicare Medical Technologies, Inc. NYN Class II 2005-12-05
K053082 BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 Baylis Medical Co., Inc. GXI Class II 2005-11-30
K052745 ASSISTO ARM SYSTEMS Geomed Medizin-Technik GmbH & Co. GWG Class II 2005-11-23
K051734 GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 Ge Healthcare Technologies HAW Class II 2005-11-23
K052374 RAPID PROGEAMMER 3.0 Advanced Neuromodulation Systems GZB Class II 2005-11-22
K053045 MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 Integra LifeSciences Corporation HBL Class II 2005-11-21
K052851 VOYAGER LINUX WITH TACTILE GUIDANCE SYSTEM (TGS) Mako Surgical Corp. HAW Class II 2005-11-18
K043367 GLAID OCULAR ELECTROPHYSIOLOGY DEVICE Lace Electronica S.R.L. GWE Class II 2005-11-17
K052182 SHIAN JIA MEEI TWO CHANNEL DIGITAL T.E.N.S. Shian Jia Meei Enterprise Co., Ltd. GZJ Class II 2005-11-04
K052213 NAVIGATION SW HIP 3.1 ON CI Brainlab AG HAW Class II 2005-11-02
K052981 BIS EEG MONITOR, MODEL BISX4 Aspect Medical Systems, Inc. OLW Class II 2005-11-01
K052904 VIRTUAL MEDICAL SYSTEMS MODEL VT3000 Scientific Imaging, Inc. JXE Class II 2005-10-27
K052178 DEPUY CAS HIP INSTRUMENTATION DePuy Orthopaedics, Inc. HAW Class II 2005-10-21
K050425 AURA-PSG Astro-Med, Inc. OLV Class II 2005-10-20
K050192 BRC SOFTWARE PRODUCT Brc Operations Pty Limited OLU Class II 2005-10-20
K052489 ACTIHEART Respironics, Inc. GWK Class II 2005-09-27
K052418 AXXESS BUTTERFLY ANCHOR Advanced Neuromodulation Systems GZB Class II 2005-09-26
K052329 WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 Innovative Neurotronics, Inc. GZI Class II 2005-09-21
K051440 MAYFIELD INFINITY SKULL CLAMP Integra Lifesciences Corp. HBL Class II 2005-09-20
K051357 DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH Digitimer , Ltd. GWF Class II 2005-09-20
K051830 NEURODRIVE SYSTEM Alpha Omega , Ltd. GZL Class II 2005-09-16
K051852 SINGLE AMPLIFIER FOR BOTOX Allergan, Inc. GWL Class II 2005-09-14
K052211 DUREPAIR DURA REGENERATION MATRIX Medtronic Neurosurgery GXQ Class II 2005-09-14
K051825 COGNITRACE Eemagine Medical Imaging Solutions GmbH GWQ Class II 2005-09-12
K052362 BIS EEG MONITOR, MODEL A-3000 Aspect Medical Systems, Inc. OLW Class II 2005-09-09
K051676 SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES Mazor Surgical Technologies , Ltd. HAW Class II 2005-09-08
K050174 BIO-STIM KIT Skylark Device & Systems Co., Ltd. GZJ Class II 2005-09-07
K050435 E-STIM II Lhasa Oms, Inc. GZJ Class II 2005-09-06
K051874 SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET Physiometrix, Inc. OLW Class II 2005-09-02
K052060 OPTI-AMP DC-POWERED Intelligent Hearing Systems GWL Class II 2005-08-31
K052066 CEEGRAPH/SLEEPSCAN NETLINK TRAVELER Bio-Logic Systems Corp. OLV Class II 2005-08-26
K052145 DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES GE Healthcare OLW Class II 2005-08-23
K052188 CUTANEOUS ELECTRODE Rhythmlink International, LLC GXY Class II 2005-08-23
K051178 MEE-1000A NEUROMASTER Nihon Kohden America, Inc. GWF Class II 2005-08-17
K051918 RESOLVE OPEN BACK HALO RINGS Jerome Medical HAX Class II 2005-08-17
K052111 XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 Excel Tech. , Ltd. GXZ Class II 2005-08-17
K050798 ECLIPSE NEUROLOGICAL WORKSTATION Axon Systems, Inc. GWF Class II 2005-08-15
K051883 DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES. GE Healthcare OLT Class II 2005-08-05
K051529 AMBU NEUROLINE GROUND Ambu, Inc. GXY Class II 2005-08-04
K051773 MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS Medtronic Inc.,Neurological Division. GZB Class II 2005-07-28
K050651 MEDTRONIC ORTHOPAEDIC TRAUMA APPLICATION Medtronic Navigation, Inc. HAW Class II 2005-07-27
K051746 ELEKTA ESARTE FRAME SYSTEM Elekta Instrument AB HAW Class II 2005-07-25
K051784 OSTEOVATION CMF BONE VOID FILLER Skeletal Kinetics, LLC GXP Class II 2005-07-20
K051724 ACUMEN IMAGE GUIDED SURGICAL SYSTEM Ebi, L.P. HAW Class II 2005-07-19
K051599 NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT Neurorecovery, Inc. GWM Class II 2005-07-19
K050739 CODMAN VPV SYSTEM, MODEL 82-3192 Codman & Shurtleff, Inc. JXG Class II 2005-07-18
K050991 THE ODFS DROPPED FOOT STIMULATOR Department of Medical Physics and Biomedical Eng. GZI Class II 2005-07-15
K051384 MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM Nuvasive, Inc. GWF Class II 2005-07-11
K051448 MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS) Medoc Ltd. Advanced Medical Systems NTU Class II 2005-06-29
K051560 NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR Micro Therapeutics, Inc. HCG Class II 2005-06-28

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