meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
42
Latest Decision
2011-11-09

Clearances · page 25 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K111645 FD TENS 2050 OR SLIDE TENS MODEL FD2050 Fuji Dynamics , Ltd. GZJ Class II 2011-11-09
K103472 NUFACE PLUS Carol Cole Company NFO Class II 2011-11-07
K112107 BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS Neurovirtual USA, Inc. GWQ Class II 2011-10-28
K110206 AESCULAP- MEITHKE SHUNT SYSTEM Aesculap, Inc. JXG Class II 2011-10-27
K112849 FIXATE TISSUE BAND Anulex Technologies, Inc. GZB Class II 2011-10-27
K112844 REHASTIM 2, REHAMOVE 2 Hasomed GmbH GZI Class II 2011-10-27
K111520 IPC POWEREASE SYSTEM Medtronic Xomed, Inc. HBE Class II 2011-10-26
K112415 LIFECARE ARM & LEG PAIN RELIEF SYSTEM Everyway Medical Instruments Co.,Ltd NUH Class II 2011-10-21
K112267 NEUROLAC(R) NERVE GUIDE Polyganics B.V., JXI Class II 2011-10-20
K102278 QUADRA BLOC TENS PLUS Gradient Technologies, LLC GZJ Class II 2011-10-20
K110021 DASH HIP Brainlab AG OLO Class II 2011-10-18
K110716 EVERYWAY LOW BACK PAIN RELIEF SYSTEM Everyway Medical Instruments Co.,Ltd NUH Class II 2011-10-18
K112156 CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM Medos International SARL JXG Class II 2011-10-17
K111737 DISPOSABLE ELECTRODE Sanibel Supply GXY Class II 2011-10-14
K112017 RAUMEDIC ICP MONITORING SYSTEM Raumedic AG GWM Class II 2011-10-11
K111647 C2 NERVEMONITOR SYSTEM WITH ACCESSORIES Inomed Medizintechnik GmbH GWF Class II 2011-10-06
K101592 ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM Cheng Medical, Corporation GXD Class II 2011-10-06
K110140 NEUROVISION NERVE LOCATOR MONITOR Neurovision Medical Products, Inc. GWF Class II 2011-09-30
K112226 HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. HCG Class II 2011-09-29
K111687 EMG SYSTEM Myotronics-Noromed, Inc. HCC Class II 2011-09-29
K111443 X12 STERILE REFLECTIVE MARKER SPHERE Pinsco Inc. Dba B & L Engineering OLO Class II 2011-09-29
K111576 NT 2000 LESIONING GENERATOR Neuro Therm, Inc. GXD Class II 2011-09-20
K111451 MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX MicroVention, Inc. HCG Class II 2011-09-20
K112385 TRAGET DETACHABLE COIL Stryker Neurovascular HCG Class II 2011-09-15
K111767 NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT Ness-Neuromuscular Electrical Stimulation Systems GZI Class II 2011-09-15
K111270 REUSABLE STIMULATING ELECTRODES Bio Protech, Inc. GXY Class II 2011-09-13
K111462 FIXATE TISSUE BAND Anulex Technologies, Inc. GZB Class II 2011-09-08
K111308 ZYTO HAND CRADLE Zyto Technologies, Inc. GZO Class II 2011-08-30
K110289 FRIENDSHIP MEDICAL DISPOSABLE PRE-GELLED AG / AGCL SURFACE ELECTRODE Xian Friendship Medical Electronics Co., Ltd. GXY Class II 2011-08-30
K083577 HARMONIE SYSTEM Stellate Systems GWQ Class II 2011-08-29
K103719 LIFECARE CONDUCTIVE GARMENTS Everyway Medical Instruments Co.,Ltd GXY Class II 2011-08-24
K111609 BOSTON BAND Boston Brace Intl., Inc. MVA Class II 2011-08-22
K112231 LCCS INSULATED SPINAL NEEDLE (RF CANNULA) Lccs Products Limited GXI Class II 2011-08-19
K111247 CRANIAL REMOLDING ORTHOSIS Orthotic Care Services, Llp MVA Class II 2011-08-15
K111176 OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM Osteomed LP GWO Class II 2011-08-15
K110204 BRAINLAB TRAUMA Brainlab AG OLO Class II 2011-08-05
K110410 MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) Nihon Kohden Corp. GYC Class II 2011-08-04
K110707 CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR Shenzhen Dongdixin Technology Co., Ltd. NUH Class II 2011-08-03
K110350 KNEEHAB XP Bio-Medical Research, Ltd. GZJ Class II 2011-08-03
K110390 ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR Handelshaus Dittman GmbH GZJ Class II 2011-07-29
K102051 PAIN BUDDY Biomedical Life Systems, Inc. NUH Class II 2011-07-29
K110376 PE-210AK SWITCH BOX Nihon Kohden Corp. GWQ Class II 2011-07-29
K110419 AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS Stryker Spine GXZ Class II 2011-07-28
K111555 CIRCUMAURAL ADHESIVE REPLACEMENT R & D Medical Products, Inc. GWJ Class II 2011-07-25
K103129 ENTROPY EASYFIT SENSOR GE Healthcare GWQ Class II 2011-07-19
K111065 STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT Howmedica Osteonics Corp. Dba Stryker Orthopeadics GWO Class II 2011-07-14
K101381 HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS Integra LifeSciences Corporation JXG Class II 2011-07-07
K110967 ENTERPRISE ELECTROPHYSIOLOGY SYSTEM Neuralynx, Inc. OMC Class II 2011-06-30
K110223 WAVEGUARD (TM) EEG CAP Eemagine Medical Imaging Solutions GmbH GXY Class II 2011-06-29
K110684 MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT Vanduzen Dba Medcad GXN Class II 2011-06-24
K110609 EPIDUCER LEAD DELIVERY SYSTEM St Jude Medical LHG Class II 2011-06-24
K111073 SURGIVISION INC. CLEARPOINT SYSTEM Surgi-Vision, Inc. ORR Class II 2011-06-22
K110509 EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 Everyway Medical Instruments Co.,Ltd LIH Class II 2011-06-20
K101627 IPLAN Brainlab AG HAW Class II 2011-06-03
K102614 AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 Bio-Medical Research, Ltd. GXY Class II 2011-06-03
K102566 OWL CANNULAE Diros Technology, Inc. GXI Class II 2011-06-03
K102251 DASH KNEE Brainlab AG OLO Class II 2011-05-17
K102598 HI-DOW-XP Hi-Dow International, Inc. NUH Class II 2011-05-13
K101763 DIOPSYS NOVA VEP VISION TESTING SYSTEM Diopsys, Inc. GWE Class II 2011-05-09
K110751 CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER Codman & Shurtleff, Inc. JXG Class II 2011-05-09
K110593 OWL RF PROBES Diros Technology, Inc. GXI Class II 2011-05-05
K103760 TITAN Interacoustics A/S GWJ Class II 2011-05-05
K103343 L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) Bioness, Inc. GZI Class II 2011-04-29
K103758 MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 MicroVention, Inc. HCG Class II 2011-04-28
K110911 RENAISSANCE SYSTEM Mazor Robotics , Ltd. HAW Class II 2011-04-28
K090277 NATUS SLEEPWORKS, MODEL 104017 Excel-Tech Ltd. (Xltek) OLZ Class II 2011-04-19
K103362 AOI CRANIAL HELMET Advanced Orthopro, Inc. MVA Class II 2011-04-18
K110240 SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1 Smith & Nephew, Inc. OLO Class II 2011-04-14
K103582 KELYNIAM CUSTOM SKULL IMPLANT (CSI) Kelyniam Global, Inc. GXN Class II 2011-04-14
K103140 NICOLET WIRELESS EEG Carefusion 209, Inc. GWL Class II 2011-04-08
K103370 RT200 Restorative Therapies, Inc. GZI Class II 2011-04-05
K103366 RT600 Restorative Therapies, Inc. GZI Class II 2011-04-04
K103428 THE ARTAS SYSTEM FROM RESTORATION ROBOTICS Restoration Robotics, Inc. ONA Class II 2011-04-04
K102990 BRAINLAB KNEE Brainlab AG OLO Class II 2011-04-04
K103829 KNEEALIGN SYSTEM Orthalign, Inc. OLO Class II 2011-04-04
K101830 ZMACHINE, MODEL DT-100 Consolidated Research of Richmond, Inc. OLV Class II 2011-03-31
DEN070014 MANDOMETER III Ab Mando OBV Class II 2011-03-31
K102115 ODFS PACE Odstock Medical, Ltd. GZI Class II 2011-03-30
K110054 NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE Zimmer Cas OLO Class II 2011-03-24
K093046 ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES Synvasive Technology, Inc. ONN Class II 2011-03-22
K103493 HEAD FIATION DEVICE (HFD 100) Imris, Inc. HBL Class II 2011-03-11
K103400 FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP Stryker Corporation OLO Class II 2011-03-07
K103206 RAUMEDIC- ICP-MONITORING SYSTEM Raumedic AG GWM Class II 2011-03-04
K102961 HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS; ACCU-FLO THREE WAY CONNECTOR; CODM Codman & Shurtleff, Inc. JXG Class II 2011-02-18
K103355 GDC 360 DETEACHABLE COIL Boston Scientific Corp HCG Class II 2011-02-16
K101979 EXPLORER LIVER (PASSIVE TRACKING) Pathfinder Therapeutics, Inc. OEW Class II 2011-02-09
K110010 NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM Blackrock Microsystems, Inc. GZL Class II 2011-02-09
K103192 NAVIGATION MARKER, REFLECTIVE MARKER SPHERES Ilumark GmbH HAW Class II 2011-02-07
K103305 PENUMBRA EMBOLIZATION COIL SYSTEM Penumbra, Inc. HCG Class II 2011-01-26
K102101 SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA Surgivision, Inc. HCD Class I 2011-01-26
K102589 CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER Codman & Shurtleff, Inc. JXG Class II 2011-01-14
K102077 MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM Cma Microdialysis AB GWM Class II 2011-01-14
K092844 GEOSOURCE Electrical Geodesics, Inc. OLX Class II 2010-12-21
K102875 CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C Integra LifeSciences Corporation GWM Class II 2010-12-20
K100205 FRONTIER DEVICES NEURO SYSTEM Folsom Metal Products, Inc. GWO Class II 2010-12-13
K102166 ELECTRO INTERSTITIAL SCAN Ld Technology, LLC GZO Class II 2010-12-10
K103008 INZONE DETACHMENT SYSTEM Boston Scientific Corp HCG Class II 2010-12-10
K093491 HIP SEXTANT INSTRUMENT SYSTEM Surgical Planning Associates OSF Class II 2010-12-09
K100668 NEMA-ST, MODEL V1.0.2 Nervomatrix, Ltd. GZJ Class II 2010-12-08
K100126 STELLATE GRIDVIEW Excel-Tech Ltd. (Xltek) OLX Class II 2010-12-03

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