meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
35
Latest Decision
2001-07-16

Clearances · page 38 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K010008 AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX Micronet Medical, Inc. GZB Class II 2001-07-16
K011429 MODEL 100 ACTIVITY MONITOR Telecom Medical, Inc. GYD Class II 2001-07-13
K011834 BIS ENGINE Aspect Medical Systems, Inc. OLW Class II 2001-07-10
K003662 SPINE WORKS COLLAR Spine Works HAX Class II 2001-07-09
K011350 STARBAND CRANIAL ORTHOSIS Orthomerica Products, Inc. OAN Class II 2001-07-03
K003759 AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR Aesculap, Inc. GWM Class II 2001-06-28
K010422 ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER Innerspace, Inc. GWM Class II 2001-06-28
K010965 A-LINE AEP MONITOR Alaris Medical Systems, Inc. OLW Class II 2001-06-27
K011584 MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF Medtronic Vascular GZB Class II 2001-06-22
K011168 NEUROGEN NERVE GUIDE Integra Lifesciences Corp. JXI Class II 2001-06-22
K010026 EMBOGOLD MICROSPHERE Biosphere Medical, Inc. HCG Class II 2001-06-21
K010897 MERIDIAN-PORTABLE Meridian Co., Ltd. GZO Class II 2001-06-19
K011534 EEG MIS MONITOR MODEL # A-2000; BIS ENGINE Aspect Medical Systems, Inc. OLW Class II 2001-06-15
K003905 ACTI-ICP MONITORING SYSTEM Innerspace, Inc. GWM Class II 2001-06-15
K010837 HANDMASTER Neuromusclar Electrical Stimulation Systems, Ltd. GZI Class II 2001-06-15
K011411 SELF-ADHESIVE ELECTRODES Pain Management Technologies GXY Class II 2001-06-13
K001897 MULTI-STIM, MODEL MS-100 Metron Medical Australia, Pty, Ltd. GZJ Class II 2001-06-12
K011433 BALLERT CRANIAL MOLDING HELMET Gema, Inc. MVA Class II 2001-06-12
K010209 ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL Biomedical Life Systems, Inc. GZJ Class II 2001-06-12
K010697 UNIQUE AMBULATORY EEG Axon Systems, Inc. GWQ Class II 2001-06-06
K003035 CLARREN HELMET Children'S Hospital & Medical Center MVA Class II 2001-06-06
K010669 NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1 Thuris Corp. GWQ Class II 2001-06-04
K011430 ACTIWARE-PLMS Mini-Mitter Co., Inc. GWQ Class II 2001-05-31
K003500 REBSTOCK YASARGIL ANEURYSM CLIP Rebstock - Instrumente GmbH HCH Class II 2001-05-30
K003630 DANMAR PRODUCTS MICHIGAN CRANIAL HELMET Danmar Products, Inc. MVA Class II 2001-05-29
K010543 KM-30 TENS ELECTRODE Katecho, Inc. GXY Class II 2001-05-23
K003589 VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT Brainlab AG HAW Class II 2001-05-21
K010728 HARMONE-SCHWARZER EEG SYSTEM Stellate Systems OLV Class II 2001-05-21
K003486 STEREOTACTIC FRAME BASED SYSTEM Stryker Instruments HAW Class II 2001-05-17
K010565 DYNATRON STS Dynatronics Corp. LIH Class II 2001-05-15
K010948 DYNATRON STS RX Dynatronics Corp. LIH Class II 2001-05-15
K010460 LIFELINES TRACKIT Lifelines , Ltd. OLV Class II 2001-05-14
K003480 BIOFIND Bio-Scan, Inc. GZO Class II 2001-05-11
K010542 SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION Surgical Navigation Specialists, Inc. HAW Class II 2001-05-08
K011204 NEUROFAX, MODELS EEG-1100A, EEG-9100A Nihon Kohden America, Inc. OLV Class II 2001-05-08
K010361 MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 Medtronic PS Medical GXR Class II 2001-05-07
K010638 NEUROPLUS, MODEL A10040, A10041, A10042, A10043 Vermont Medical, Inc. GXY Class II 2001-05-03
K002565 BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE) Baylis Medical Co., Inc. GXD Class II 2001-05-03
K002334 MACROPORENS CRANILOC Macropore Biosurgery, Inc. GXR Class II 2001-05-02
K010782 TRANSAMERICAN TENS Transamerica Medical Systems GZJ Class II 2001-04-27
K010273 CRANIAL MOLDING ORTHOSIS Orthotic Solutions, Inc. MVA Class II 2001-04-25
K010969 NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES Stryker Instruments GXD Class II 2001-04-20
K010341 MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, Medtronic PS Medical GWG Class II 2001-04-20
K010086 REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED) Excel Tech. , Ltd. GWQ Class II 2001-04-09
K010092 XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED) Excel Tech. , Ltd. GWF Class II 2001-04-02
K010089 REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED) Excel Tech. , Ltd. GWQ Class II 2001-03-26
K010090 XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED) Excel Tech. , Ltd. GWF Class II 2001-03-26
K010088 REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED) Excel Tech. , Ltd. GWQ Class II 2001-03-26
K010087 XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP Excel Tech. , Ltd. GWF Class II 2001-03-19
K010019 STERILE SUBDERMAL NEEDLE ELECTRODES Nicolet Biomedical, Inc. GXZ Class II 2001-03-19
K010084 REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP Excel Tech. , Ltd. GWQ Class II 2001-03-16
K010085 EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) Excel Tech. , Ltd. OMB Class II 2001-03-15
K010427 LORENZ FIDUCAIL SCREW Walter Lorenz Surgical, Inc. HAW Class II 2001-03-15
K002297 YORAMED, MODEL T-202 United Yoram Distributors, Inc. GZJ Class II 2001-03-15
K001353 MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM Biomedical Ent., Inc. HBW Class II 2001-03-13
K010548 MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) Radionics, A Division of Tyco Healthcare Group LP HAW Class II 2001-03-12
K003369 LIFECARE COMPACT TENS DEVICE Lifecare , Ltd. GZJ Class II 2001-03-08
K003699 MEDIVISION IGS SYSTEM Medivision (U.S.A.), Inc. HAW Class II 2001-02-27
K010059 ENGPLUS Western Systems Research, Inc. GWN Class II 2001-02-27
K003347 ORTHOPILOT Kinamed, Inc. HAW Class II 2001-02-23
K003776 MICROTARGETING DRIVE SYSTEM FHC, Inc. HAW Class II 2001-02-23
K003268 Z-TOUCH Brainlab AG HAW Class II 2001-02-22
K003914 MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES Medtronic PS Medical GWG Class II 2001-02-22
K003507 MEDRELIEF Healthonics, Inc. GZJ Class II 2001-02-21
K003612 MICROSPEED EC MOTORSYSTEM GD650/GD653 Aesculap, Inc. HBC Class II 2001-02-20
K003591 TENSCARE, MODEL TENS XL-2 Tenscare, Ltd. GZJ Class II 2001-02-14
K010150 64 CHANNEL EEG / MODEL NUMBER EX-NW-64 Excel Tech. , Ltd. GWQ Class II 2001-02-09
K003499 REMVIEW SLEEP RECORDER, MODEL 320 Respironics, Inc. LEL Class II 2001-02-09
K993600 MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841 Nisha Communication Industries LIH Class II 2001-02-05
K001781 CURRY MULTIMODAL NEUROIMAGING SOFTWARE Neurosoft, Inc. OLX Class II 2001-02-05
K002227 WANDY SILICONE CONDUCTIVE RUBBER PAD Wandy Rubber Industrial Co., Ltd. GXY Class II 2001-02-02
K002219 WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE Wandy Rubber Industrial Co., Ltd. GXY Class II 2001-02-02
K993229 ANALGESIC PULSER, MODEL AP-439 Johari Electro-Tech Co. GZJ Class II 2001-02-02
K003644 EYETECT TREMOR MONITOR UNIT (TMU) Eyetect, LLC GWN Class II 2001-02-01
K010091 EEG WITH VIDEO, MODEL EX-NW Excel Tech. , Ltd. GWQ Class II 2001-02-01
K003519 YASARGIL PERMANENT ANEURYSM CLIPS Aesculap, Inc. HCH Class II 2001-01-29
K001678 PVA FOAM EMBOLIZATION PARTICLES Surgica Corp. HCG Class II 2001-01-25
K003487 STIMATE N601 TENS Everyway Medical Instruments Co.,Ltd GZJ Class II 2001-01-24
K004027 STRYKER REMOTE SURGICAL PLANNING SYSTEM Stryker Instruments HAW Class II 2001-01-24
K000852 RENEW NEUROSTIMULATION SYSTEM Advanced Neuromodulation Systems GZF Class II 2001-01-19
K003508 NC-STAT Neurometrix, Inc. JXE Class II 2001-01-17
K003231 HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3 Home Medical Services GZJ Class II 2001-01-12
K003258 MS-ONE, MODEL MS-1 Home Wellness West GZJ Class II 2001-01-12
K002056 MICRUS MICROCOIL DELIVERY SYSTEM, MDS03 Micrus Corp. HCG Class II 2001-01-11
K003154 MIZAR, BASIS BE, SANDMAN DIGITAL Eb Neuro S.P.A. GWL Class II 2001-01-05
K003127 REGAIN DESKTOP Srs Medical Systems, Inc. HCC Class II 2001-01-04
K003367 ORION PLATINUM Srs Medical Systems, Inc. HCC Class II 2001-01-04
K003111 STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES Stryker Instruments HAW Class II 2001-01-04
K003175 COMPUMEDICS SIESTA SYSTEM Compumedics Limited OLV Class II 2000-12-27
K003681 BIO-LOGIC SLEEPSCAN NETLINK Bio-Logic Systems Corp. OLV Class II 2000-12-21
K003564 HAKIM PROGRAMMER AND TRANSMITTER Codman & Shurtleff, Inc. JXG Class II 2000-12-20
K003038 AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A Agilent Technologies Deutschland GmbH OLW Class II 2000-12-15
K002985 ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS Ics Medical Corp. GWJ Class II 2000-12-13
K003201 STEALTHSTATION TREATMENT GUIDANCE PLATFORM Medtronic Surgical Navigation Technologies HAW Class II 2000-12-12
K002970 SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 Medical Designs, LLC JXG Class II 2000-12-12
K002969 XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8 Xltek GWF Class II 2000-12-08
K001669 HANGER CRANIAL BAND Hanger Orthopedic Group, Inc. MVA Class II 2000-12-08
K002893 FLUOROLAB PLUS Z-Kat, Inc. HAW Class II 2000-12-04
K001521 SOFTSENS Integrated Biosensing Technologies GXY Class II 2000-11-27
K002765 LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE Integra Neurosciences GWM Class II 2000-11-24

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