meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
37
Latest Decision
2012-09-10

Clearances · page 24 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K121822 DELICOT American Surgical Company, LLC HBA Class II 2012-09-10
K121353 MINI PATCH Well-Life Healthcare Limited NUH Class II 2012-09-07
K113321 TENS BACK PAIN RELIEF SYSTEM Savia Limited NUH Class II 2012-09-04
K122353 CRAINFIX 2 TITANIUM CLAMP SYSTEM Aesculap, Inc. GXN Class II 2012-08-30
K121264 TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE Medtronic Surgical Technologies HBE Class II 2012-08-27
K121304 OSTEOMED CRANIAL DISTRACTION SYSTEM Osteomed PBJ Class II 2012-08-22
K120835 DYNATRON THERMOSTIM PROBE-DONE Dynatronics Corporation GXY Class II 2012-08-20
K120500 THE PAIN PILOT (A.K.A PAIN PILOT) Hollywog, LLC NUH Class II 2012-08-20
K120398 WITOUCH PRO Hollywog, LLC GZJ Class II 2012-08-16
K121102 OSTEOSYMBIONICS PEEK CRANIAL IMPLANT Osteosymbionics, LLC GXN Class II 2012-08-08
K121996 BE PLUS LTM AMPLIFIER GWI AMPLIFIER Eb Neuro S.P.A. GWL Class II 2012-08-03
K122118 HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM Codman & Shurtleff, Inc. JXG Class II 2012-08-03
K121184 SENSUS Neurometrix, Inc. GZJ Class II 2012-08-02
K121578 ATOM 1 (MODEL: BRC 2200) Bioelectric Research Corporation GZJ Class II 2012-07-31
K120511 AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM Leto Enterprise , Ltd. NFO Class II 2012-07-30
K113073 IO-TOME DEVICE Baxano, Inc. HAE Class II 2012-07-27
K113544 ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER Prospera Corporation GZJ Class II 2012-07-27
K121950 MICROTARGETING XL STAR DRIVE SYSTEM FHC, Inc. HAW Class II 2012-07-26
K120569 GEMORE TENS SYSTEM Gemore Technology Co, Ltd. GZJ Class II 2012-07-20
K121159 INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER Integra Lifescience Corportation GWM Class II 2012-07-20
K121253 MERIDIAN CRANIAL PERFORATOR Adeor Medical Technologies GmbH HBF Class II 2012-07-17
K121347 PRESSON ELECTRODE Rhythmlink International, LLC GXZ Class II 2012-07-12
K120812 RENAISSANCE Mazor Robotics , Ltd. HAW Class II 2012-07-12
K120260 ICTA Excel-Tech Ltd. (Xltek) OMB Class II 2012-06-29
K120415 CRYO-TOUCH III Myoscience, Inc. GXH Class II 2012-06-22
K120447 X4 Advanced Brain Monitoring, Inc. OMC Class II 2012-06-20
K112817 MICROEEG SYSTEM Bio-Signal Group Corporation GWQ Class II 2012-06-19
K120600 DURAGEN SECURE DURAL REGNERATION MATRIX Integra Life Sciences GXQ Class II 2012-06-15
K120098 STERILE DISPOSABLES FOR MER Alpha Omega Engineering , Ltd. GZL Class II 2012-06-12
K120352 STRYKER QUIKFLAP STERILE PROCEDURE PACK Stryker GWO Class II 2012-06-11
K120494 DISPOSABLE ADHESIVE SURFACE ELECTRODE Spes Medica Srl GXY Class II 2012-06-11
K113785 ADHERENT VISUAL STIMULATOR GOGGLES Anschel Technology, Inc. GWE Class II 2012-06-06
K121064 MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM Mako Surgical Corporation OLO Class II 2012-06-06
K120691 BRAIN PORT Nico Corporation GZT Class II 2012-06-05
K120054 ULTIMA NEO Pain Management Technologies GZJ Class II 2012-06-05
K120633 MAYFIELD SKULL CLAMP Integra LifeSciences Corporation HBL Class II 2012-05-24
K120559 AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM Aesculap, Inc. JXG Class II 2012-05-24
K110644 PRAEZIS PLUS Tatramed Spol. S.R.O. HAW Class II 2012-05-24
K112881 NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) Nexstim OY GWF Class II 2012-05-22
K120104 VISIONSEARCH 1 Visionsearch Pty, Ltd. GWE Class II 2012-05-21
K120516 LONG LIFE PADTM Omron Healthcare, Inc. GXY Class II 2012-05-17
K112288 JIAJIAN TENS Wuxi Jiajian Medical Instrument Co., Ltd. GZJ Class II 2012-05-02
K113088 HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) Innerspace, Inc. GWM Class II 2012-05-02
K120979 CAREFUSION NICOLET EDX Carefusion 209, Inc. GWF Class II 2012-04-25
K120908 HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. HCG Class II 2012-04-25
K112094 BRAIN BIOPSY NEEDLE Ad-Tech Medical Instrument Corp HAW Class II 2012-04-24
K120853 NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, Bioness, Inc. GZI Class II 2012-04-20
K113611 RAPID PROGRAMMER St Jude Medical GZB Class II 2012-04-20
K120850 TARGET DETACHABLE COIL Stryker Neurovascular HCG Class II 2012-04-17
K120252 RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM Raumedic AG GWM Class II 2012-04-11
K113533 NEURO CHECK DEVICE WITH IO-FLEX WIRE Baxano, Inc. HAE Class II 2012-04-11
K120686 ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM Codman & Shurtleff, Inc. HCG Class II 2012-04-04
K120330 PENUMBRA COIL SYSTEM/PENUMBRA COIL 400 Penumbra, Inc. HCG Class II 2012-04-02
K112351 ULTRA BEAUTY Johari Digital Healthcare , Ltd. NFO Class II 2012-03-30
K111558 SURGICASE GUIDE Materialise NV HAW Class II 2012-03-27
K113748 IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) Imris, Inc. HBL Class II 2012-03-23
K112469 GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM Sonowand AS HAW Class II 2012-03-23
K113117 NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX Nihon Kohden America, Inc. GWQ Class II 2012-03-22
K112392 HIVOX BIOTEK INC. Hivox Biotek, Inc. NUH Class II 2012-03-19
K120485 NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P Nihon Kohden America, Inc. OMA Class II 2012-03-16
K112052 CAREFUSION NICOLET EDX Carefusion 209, Inc. GWF Class II 2012-03-15
K112077 HBIDB - HUMAN BRIAN INDEX SOFTWARE Corscience GmbH & Co. KG OLU Class II 2012-03-09
K113822 QUADRASPHERE 30 TO 60 Biosphere Medical, Inc. HCG Class II 2012-03-08
K120274 DELTAMAXX 18 MICROCOIL SYSTEM Codman and Shurtleff, Inc. HCG Class II 2012-03-02
K103081 COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE Biom'Up Sas JXI Class II 2012-03-02
K111654 FD TENS 2070 Fuji Dynamics , Ltd. GZJ Class II 2012-03-01
K112507 RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM Mako Surgical Corporation OLO Class II 2012-03-01
K113037 PAIN-AID Pdi Works, LLC NUH Class II 2012-03-01
K113805 FIXATE TISSUE BAND Anulex Technologies, Inc. GZB Class II 2012-02-23
K112812 LEFORTE NEURO SYSTEM BONE PLATE Jeil Medical Corporation GWO Class II 2012-02-22
K112353 GEODESIC EEG MOBILE 100 (GEM 100) Electrical Geodesics, Inc. GWQ Class II 2012-02-17
K113526 CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM Medos International SARL JXG Class II 2012-02-16
K113724 ELECTROPULSE-COSMETIC Pain Relief Technologies NFO Class II 2012-02-15
K112319 ELECTRO-CAP SYSTEM Electro-Cap Intl., Inc. GXY Class II 2012-01-27
K113273 SPOTLIGHT ACCESS SYSTEM Johnson & Johnson GZT Class II 2012-01-27
K112312 THERATRODE Phoenix Medical Devices, Llp GXY Class II 2012-01-25
K112934 NEUROTECH RECOVERY Bio-Medical Research, Ltd. GXY Class II 2012-01-20
K113071 SYNTHECEL DURA REPLACEMENT DEVICES Synthes GXQ Class II 2012-01-09
K112258 NEUROTECH PLUS Bio-Medical Research, Ltd. GZJ Class II 2012-01-09
K111717 ELECTRO-GEL Electro-Cap Intl., Inc. GYB Class II 2012-01-05
K112557 STRYKER UNIVERSAL NEURO 3 SYSTEM Stryker GWO Class II 2012-01-05
K111055 GALAXY SYSTEM; JUPITER Personal Health Institute International OLV Class II 2011-12-21
K111514 SBV2, MULTICHARGER MODEL MC10V2 Sleep Performance D.B.A. Fatigue Science LEL Class II 2011-12-16
K113457 HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. HCG Class II 2011-12-16
K113476 ANSPACH DISSECTION TOOLS The Anspach Effort, Inc. HBE Class II 2011-12-16
K112913 SPOTLIGHT ACCESS SYSTEM Johnson & Johnson GZT Class II 2011-12-16
K113400 FIXATE TISSUE BAND Anulex Technologies, Inc. GZB Class II 2011-12-16
K113412 TARGET DETACHABLE COIL Stryker Neurovascular HCG Class II 2011-12-13
K102494 THE BUZZ FACIAL TONING SYSTEM Daka International , Ltd. NFO Class II 2011-12-09
K110068 MODEL PM3030 Omron Healthcare, Inc. NUH Class II 2011-12-08
K103103 PRESSON ELECTRODE Persyst Development Corp. GXZ Class II 2011-12-08
K112485 H-WAVE Electronic Waveform Lab, Inc. GZJ Class II 2011-12-06
K111811 BENDINI(TM) SPINAL ROD BENDING SYSTEM Nuvasive, Inc. OLO Class II 2011-12-05
K112181 HYDROCOIL(R) EMBOLIC SYSTEM (HES) MicroVention, Inc. HCG Class II 2011-12-01
K113228 RENAISSANCE SYSTEM Mazor Robotics , Ltd. HAW Class II 2011-12-01
K110560 MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER Medtronic Neurosurgery JXG Class II 2011-11-18
K112214 OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS St. Jude Medical Neuromodulation GZB Class II 2011-11-17
K111843 ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM Smith & Nephew Inc., Endoscopy Div. OLO Class II 2011-11-14
K111557 X-FORCE Seven Seas Distribtion and Manufacturing, LLC NYN Class II 2011-11-10
K103031 BMR FACE Bio-Medical Research, Ltd. NFO Class II 2011-11-10

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