meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
38
Latest Decision
2005-06-28

Clearances · page 32 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K050954 MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. HCG Class II 2005-06-28
K050036 FES CYCLE ERGOMETER, MODEL RT300-S Restorative Therapies, Inc. GZI Class II 2005-06-27
K051425 NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR Micro Therapeutics, Inc. HCG Class II 2005-06-22
K051029 STELTHSTATION WIRELESS SURGEON MOUSE Medtronic Surgical Navigation HAW Class II 2005-06-08
K031196 SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM Praxim HAW Class II 2005-06-07
K050438 STEALTHSTATION SYSTEM UPDATE Medtronic Surgical Navigation Technologies HAW Class II 2005-06-02
K040871 FACEMASTER FACIAL TONING SYSTEM Facemaster of Beverly Hills, Inc. NFO Class II 2005-06-01
K041897 MAYFIELD ACCISS II IMAGE GUIDED SURGERY SYSTEM, MODEL 2002-01 Schaerer Mayfield USA, Inc. HAW Class II 2005-06-01
K042297 ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES Acta Vascular Systems, Inc. HCG Class II 2005-06-01
K043442 STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE Stryker Instruments GXI Class II 2005-05-31
K050897 NAVIPRO SHOULDER SOFTWARE MODULE Kinamed, Inc. HAW Class II 2005-05-24
K050098 DDAT OMT Ddat(Uk), Ltd. GWN Class II 2005-05-23
K050922 ANS SCS ACCESSORY KIT Advanced Neuromodulation Systems GZB Class II 2005-05-18
K042912 INTERX5000 Neuro Resource Group, Inc. GZJ Class II 2005-05-17
K050702 NEUROSYSTEMS 1TM MONITOR Neurosystems, LLC GWM Class II 2005-05-17
K050973 MODIFICATION TO: VOYAGER LINUX Mako Surgical Corp. HAW Class II 2005-05-17
K042543 IPLAN! DIGITAL TEMPLATING Brainlab AG HAW Class II 2005-05-17
K050788 EVERLIFE Everlife Medical Instrument Co., Ltd. GXY Class II 2005-05-13
K050469 EZ-STIK ELECTRODES Naimco, Inc. GXY Class II 2005-05-13
K050720 NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100 Integra Neurosciences GWM Class II 2005-05-11
K050835 DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES GE Healthcare OLW Class II 2005-05-06
K050325 DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE Technomed Europe GXZ Class II 2005-05-05
K050573 NEUROLAC NERVE GUIDE Polyganics B.V., JXI Class II 2005-05-04
K050833 ELECTRODE JUNCTION BOX, MODEL JE-921A Nihon Kohden America, Inc. OLV Class II 2005-04-29
K050543 NEXUS DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. HCG Class II 2005-04-27
K050752 AESCULAP ORTHOPILOT 2 THA V 2.0 Aesculap, Inc. HAW Class II 2005-04-27
K050188 EPIGUARD Episafe Medical Devices, Ltd. JXL Class II 2005-04-27
K050194 AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES Axon Systems, Inc. GXZ Class II 2005-04-26
K050772 NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 Image-Guided Neurologics, Inc. HAW Class II 2005-04-21
K050633 TRIAL CABLE RETENTION CLIP Advanced Neuromodulation Systems GZB Class II 2005-04-21
K050615 STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000 Stryker Instruments HAW Class II 2005-04-21
K042721 KOLIBRI SPINE Brainlab AG HAW Class II 2005-04-19
K050700 MATRIX STRETCH RESISTANT (SR) COILS Boston Scientific Corp HCG Class II 2005-04-15
K050706 HARMONY PORT SYSTEM, MODEL 1907 SERIES Spinal Concepts, Inc. GZT Class II 2005-04-15
K050377 NBD HEAD SCREW New Business Development, LLC HAW Class II 2005-04-07
K050628 ANSPACH COUPLER The Anspach Effort, Inc. HBE Class II 2005-04-07
K050740 MICROWARE 200 Microware, Inc. GZJ Class II 2005-04-06
K050319 MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 Integra Lifesciences Corp. HBL Class II 2005-03-31
K042384 NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM Cyberkinetics, Inc. (Cki) GZL Class II 2005-03-29
K042626 NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM Cyberkinetics, Inc. GWQ Class II 2005-03-28
K050272 CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS Cryomedical Instruments, Ltd. GXH Class II 2005-03-24
K042208 ISIS MER SYSTEM/ELEKTA MER SYSTEM Inomed Medizintechnik GmbH GZL Class II 2005-03-18
K050084 COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; Cosman Medical, Inc. GXI Class II 2005-03-17
K043491 ENFANTTM Diopsys, Inc. GWE Class II 2005-03-16
K042711 MODEL BMLS03-7 Biomedical Life Systems, Inc. GZJ Class II 2005-03-14
K042107 TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001 Tung FU Electric Co., Ltd. GZJ Class II 2005-03-09
K043223 DEPUY CAS KNEE INSTRUMENTATION DePuy Orthopaedics, Inc. HAW Class II 2005-03-04
K041838 MPS (OR MPS-T) Innerspace, Inc. GWM Class II 2005-03-01
K041908 CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS) Medoc Ltd. Advanced Medical Systems NTU Class II 2005-02-25
K050313 BIS SRS (SEMI-RESUABLE SENSOR) Aspect Medical Systems, Inc. GWY Class I 2005-02-24
K043407 INF 4160, MODEL D-FJ27F Fuji Dynamics Limited LIH Class II 2005-02-11
K042513 VECTORVISION OSTEOTOMY Brainlab AG HAW Class II 2005-02-10
K043334 BONE SOURCE HAC RAPID SETTING CEMENT Stryker Instruments GXP Class II 2005-02-09
K050044 MEDTRONIC CLIP GUN KIT Medtronic Neurosurgery HBO Class II 2005-02-07
K043091 NAVIGUS NEXDRIVE, MODEL MI-3000 Image-Guided Neurologics, Inc. HAW Class II 2005-02-07
K050143 OMNIPRO SYSTEM Mays and Associates, Inc. OLV Class II 2005-02-01
K041992 MEDTRONIC STRATAVARIUS Medtronic Neurosurgery JXG Class II 2005-01-28
K043309 GEODESIC PHOTOGRAMMETRY SYSTEM Electrical Geodesics, Incorporated GWQ Class II 2005-01-26
K050035 ELEKTA NEUROMAG WITH MAXWELL FILTER Elekta Neuromag OY OLX Class II 2005-01-25
K043396 INTEGRITY, MODEL V500 Vivosonic, Inc. GWJ Class II 2005-01-24
K042315 CEREBRAL STATE MONITOR - CSM Danmeter A/S OLW Class II 2005-01-21
K043536 NAVITRACK SYSTEM - S&N IMAGE FREE KNEE Orthosoft, Inc. HAW Class II 2005-01-14
K042974 MEDICON VIPAIR HIGH SPEED SYSTEM Medicon EG HBB Class II 2005-01-13
K042512 VECTORVISION ACL Brainlab AG HAW Class II 2005-01-13
K043009 BRAINET KIT Jordan Neuroscience, Inc. GXY Class II 2005-01-12
K043427 DURAGEN II DURAL REGENERATION MATRIX Integra Lifesciences Corp. GXQ Class II 2005-01-12
K043088 MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE Medtronic Surgical Navigation Technologies HAW Class II 2005-01-05
K030526 PEDIGUARD NERVE DETECTOR SYSTEM Spine Vision, Inc. GWF Class II 2004-12-29
K042414 VISIOPLAST ACRYLIC RESIN Tecres GXP Class II 2004-12-29
K043280 MIMIX MP BONE VOID FILLER Biomet, Inc. GXP Class II 2004-12-21
K042825 ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM Integra LifeSciences Corporation JXG Class II 2004-12-21
K043128 OLYMPUS ENDOARM Olympus Corporation GWG Class II 2004-12-21
K042057 INFINITY ELECTROTHERAPY SYSTEM Empi LIH Class II 2004-12-17
K042783 ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM The Anspach Effort, Inc. HBE Class II 2004-12-17
K042385 DOC BAND-POSTOP Cranial Technologies, Inc. MVA Class II 2004-12-17
K042481 POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 Sophysa SA JXG Class II 2004-12-14
K041477 PATHFINDER Armstrong Healthcare Limited HAW Class II 2004-12-09
K043041 AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) Aesculap, Inc. HCH Class II 2004-12-09
K040888 DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE Collagen Matrix, Inc. GXQ Class II 2004-12-01
K041388 COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1 Biomedical Life Systems, Inc. GZJ Class II 2004-11-23
K041978 REPROCESSED DIAMOND BURS Alliance Medical Corp. NLN Class II 2004-11-23
K041172 BASBA E-MACHINE Basba, Inc. GZJ Class II 2004-11-18
K042359 SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL Medical Designs, LLC JXG Class II 2004-11-17
K042039 FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 Cleveland Medical Devices, Inc. OLV Class II 2004-11-17
K042559 GEM-TWIN TENS/ MODELS GM3XY/Z Gemore Technology Co, Ltd. GZJ Class II 2004-11-17
K042986 MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM Synthes (Usa) GXR Class II 2004-11-17
K042231 GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES Biocompatibles UK Limited HCG Class II 2004-11-12
K042350 TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR Cadwell Laboratories, Inc. GWF Class II 2004-11-03
K040021 SHUNTCHECK (PROMETHEUS 1) Samuel Neff M.D. JXG Class II 2004-11-02
K042375 SMK, CX, CXE, RCN Technomed Europe GXI Class II 2004-10-26
K041703 IPLAN! Brainlab AG HAW Class II 2004-10-22
K042728 CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM Novus Monitoring, Ltd. GWM Class II 2004-10-22
K042539 GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL Boston Scientific Corp HCG Class II 2004-10-19
K042391 KOLIBRI IMAGE GUIDED SURGERY SYSTEM Brainlab AG HAW Class II 2004-10-19
K042465 PS MEDICAL STRATA II VALVE Medtronic Neurosurgery JXG Class II 2004-10-19
K041899 VECTORVISION UNI-KNEE Brainlab AG HAW Class II 2004-10-06
K042529 BALANCEBACK VNG SYSTEM Fall Prevention Technologies, LLC GWN Class II 2004-10-06
K042558 EQUI-FLOW VALVE AND SHUNT SYSTEM Integra Neurosciences Implants S.A. JXG Class II 2004-10-06
K040334 NAVIGUS PASSIVE PROBE, MODEL NP-1000 Image-Guided Neurologics, Inc. HAW Class II 2004-10-04
K040311 SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-331 Shian Jia Meei Enterprise Co., Ltd. GZJ Class II 2004-10-01

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