meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
33
Latest Decision
1995-10-27

Clearances · page 45 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K942631 ELECTROCARE Waco Corp. GZJ Class II 1995-10-27
K945585 COMAN(R) CU-11 MODEL NUMBER 82-6634 Johnson & Johnson Professionals, Inc. GWM Class II 1995-10-26
K945120 THYMATRON 2000 ELECTROCONVULSIVE SYSTEM Somatics, Inc. QGH Class II 1995-10-26
K944463 CRW-1 SYSTEM Radionics Software Applications, Inc. HAW Class II 1995-10-26
K954021 EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) Johnson & Johnson Professionals, Inc. JXG Class II 1995-10-24
K953732 TECA PREMIERE Medelec , Ltd. GWJ Class II 1995-10-19
K944595 CORDIS HORIZONTAL-VERICAL VALVE SYSTEM Cordis Corp. JXG Class II 1995-10-19
K943101 GALVANIC SKIN RESPONSE DEVICE Global Ent. GZO Class II 1995-10-18
K953554 NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES Nobles-Lai Engineering, Inc. GWG Class II 1995-10-18
K935456 REGULUS MEASUREMENT UNIT Compass Intl., Inc. HAW Class II 1995-10-13
K941342 PAIN DOC Regulatory & Marketing Services, Inc. GZB Class II 1995-10-13
K953685 INSTRUMENT SCOPE Clarus Medical Systems, Inc. GWG Class II 1995-10-12
K953449 MODEL 1207, HYDRODOT NEUROMONITORING SYSTEM ADHESIVE PADS Physiometrix, Inc. GWQ Class II 1995-10-12
K954069 ACE CERVICAL TRACTION HALOZS, TONGS & PINS Ace Medical Co. HAX Class II 1995-10-12
K953219 22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN Chalgren Enterprises, Inc. GXY Class II 1995-10-06
K953220 32MM NICKEL PLATED DISC ELECTRODE Chalgren Enterprises, Inc. GXY Class II 1995-10-06
K953173 NONPOWERED NEUROSURGICAL INSTRUMENT United States Surgical, A Division of Tyco Healthc GWG Class II 1995-10-03
K940973 MULLAN GANGLION MICROCOMPRESSION SET Cook, Inc. HAO Class I 1995-09-29
K940600 STIMULATOR, NERVE, TRANSCUTANEOUS, (PAIN RELIEF) 84-GZJ Progressive Concepts, Inc. GZJ Class II 1995-09-29
K931609 CHARTR ENG SYSTEM Ics Medical Corp. GWM Class II 1995-09-26
K952176 DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-K Medicotest, Inc. GXY Class II 1995-09-25
K951213 RELAXPLUS Ultramind International , Ltd. HCC Class II 1995-09-20
K952080 CLARITY SYSTEM II Sonamed Corp. GWJ Class II 1995-09-19
K944547 DANTEC KEYPOINT Mckenna & Cuneo GWF Class II 1995-09-19
K945633 NEURO CHANNEL ENDOSCOPE MODEL 2232 Clarus Medical Systems, Inc. GWG Class II 1995-09-19
K951258 PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT Pudenz-Schulte Medical Research Corp. JXG Class II 1995-09-18
K944615 A620 EEG Stoelting Co. HCC Class II 1995-09-18
K945286 THE BAGNOLI-2 EMG SYSTEM Delsys, Inc. HCC Class II 1995-09-15
K950349 DYNATRON 950 Dynatronics Corp. LIH Class II 1995-09-13
K950348 DYNATRON 650 Dynatronics Corp. LIH Class II 1995-09-13
K946094 CADWELL EASY AMBULATORY EEG Cadwell Laboratories, Inc. GWQ Class II 1995-09-12
K951256 DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC) Target Therapeutics HCG Class II 1995-09-08
K946033 LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE Leibinger GmbH HAW Class II 1995-09-01
K942769 BIOINTEGRATOR, BIOINTEGRATOR PLUS Bio Research Institute HCC Class II 1995-09-01
K941577 DYNATRON 550 Dynatronics Corp. LIH Class II 1995-09-01
K941461 DYNATRON 850 Dynatronics Research Corp. LIH Class II 1995-09-01
K932571 TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 Tomey Corporation USA GWE Class II 1995-08-31
K952459 MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL Medtronic Vascular GZB Class II 1995-08-30
K951594 BIO-LOGIC AUTOMATIC EVENT ANALYSIS Bio-Logic Systems Corp. OMB Class II 1995-08-22
K950647 ULTRACELL NEURO SPONGES Ultracell Medical Technologies, Inc. HBA Class II 1995-08-15
K952089 RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE Rich-Mar Corp. LIH Class II 1995-08-11
K951314 TRUEFILL PVA PARTICLES Cordis Neurovascular, Inc. HCG Class II 1995-08-08
K945826 J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS Medical Device Inspection Co., Inc. HCC Class II 1995-08-04
K944222 CODMAN-MEDOS VALVE SHUNT SYSTEM Johnson & Johnson Professionals, Inc. JXG Class II 1995-07-28
K944543 BIOFLEX GARMENTS, ASSORTED MODELS Bioflex, Inc. GXY Class II 1995-07-19
K951724 QUANTITATIVE EEG ANALYSIS SOFTWARE Neuroconcepts, Inc. OLT Class II 1995-07-14
K950154 1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES Neuro Navigational Corp. GWG Class II 1995-07-14
K951507 PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE Neuroconcepts, Inc. GWQ Class II 1995-07-14
K945296 CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160 Clarus Medical Systems, Inc. GWG Class II 1995-07-14
K946299 PGS123 AND HVS-123 Skylark Device Co., Ltd. GZJ Class II 1995-06-26
K951350 MUSCLESENSE ELECTROMYOGRAPHY DEVICE Smith and Nephew Donjoy, Inc. HCC Class II 1995-06-23
K950782 MEDI-TRAC EEG ELECTRODE Graphic Controls Corp. GXY Class II 1995-06-22
K941959 VERSATELL; VERSATELL-S Progressive Concepts, Inc. HCC Class II 1995-06-21
K951969 MYOEXORCISER II FUAL Verimed Holdings, Inc. HCC Class II 1995-06-14
K932050 NH-2002 New Horizon Health Care QJQ Class II 1995-06-05
K941923 STERILE TREATMENT ELECTRODE Staodyne, Inc. GZJ Class II 1995-06-02
K933197 THE SIGNATURE SERIES, M IV Progressive Electrical Therapeutics GZJ Class II 1995-06-02
K950956 DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE Bio-Vascular, Inc. GXQ Class II 1995-06-02
K942428 CMT-1000 Ems, Inc. LIH Class II 1995-05-23
K944678 NIHON KOHDEN ELECTROENCEPHALOGRAPH Nihon Kohden America, Inc. GWQ Class II 1995-05-22
K940273 NOBLES-LAI VIDEO IMAGING SYSTEM Visioneering, Inc. GWG Class II 1995-05-22
K930578 AT33 EMG Autoject Systems, Inc. HCC Class II 1995-05-19
K951492 RIB RESECTOR United States Surgical, A Division of Tyco Healthc HAO Class I 1995-05-18
K943541 75K STAIGHT DRILL Stryker Corp. HBE Class II 1995-05-18
K930576 AT42 Autoject Systems, Inc. HCC Class II 1995-05-18
K930577 AT64 SCR Autoject Systems, Inc. HCC Class II 1995-05-18
K950270 NMI SOFTWARE Nicolet Biomedical, Inc. OMB Class II 1995-05-15
K944280 TRANSAMERICAN CLASSIC TENS Transamerica Biomedical, Inc. GZJ Class II 1995-05-15
K950208 NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM Nihon Kohden America, Inc. GWF Class II 1995-05-10
K950315 CORDIS CSF RESERVOIR Cordis Corp. LKG Class II 1995-05-09
K944833 DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM New England Medical Monitoring Co. OMB Class II 1995-05-04
K941815 ISOTRON III Excel Tech. , Ltd. LIH Class II 1995-05-03
K940811 BRAINTRACE Brainstorms Monitoring Corp. OLT Class II 1995-05-02
K946318 MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE CABLE Physiometrix, Inc. GXY Class II 1995-04-24
K950425 TECOTHANE 55D Medtronic Vascular GZF Class II 1995-04-19
K943537 MODEL 3470 X-TREL RF RECEIVER Medtronic Vascular GZB Class II 1995-04-12
K941856 PREMIER PROMAX BITE GUARD Premier Dental Products Co. JXL Class II 1995-04-05
K950117 PERSYST SPIKE DETECTOR Persyst Consulting Services, Inc. OMB Class II 1995-04-05
K932769 CAMINO VENTRICULAR DRAINAGE SYSTEM Camino Laboratories, Inc. JXG Class II 1995-03-30
K950491 RICH-MAR CARBON ELECTRODES Rich-Mar Corp. GXY Class II 1995-03-29
K940759 FORTE ES Chattanooga Group, Inc. GZI Class II 1995-03-16
K946252 STEREOPLAN Radionics Software Applications, Inc. HAW Class II 1995-03-14
K934779 AGRAM SPYRAL ELECTRODE Agram Export-Import Co. GXZ Class II 1995-03-14
K912456 SUNDT SLIM-LINE GRAFT CLIPS Codman & Shurtleff, Inc. HCH Class II 1995-03-10
K944234 TCD OR TCD NEUROPATHY STAR Jcm Management & Planning Co. GWI Class I 1995-03-08
K940648 CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER Cordis Corp. GWM Class II 1995-03-01
K940050 FOCUS EMG Fasstech HCC Class II 1995-02-24
K943009 SMD ELECTRODES Scientific Medical Devices, Inc. GXY Class II 1995-02-21
K943583 KERRISON RONGEURS Enterprise Medical Corp. HAE Class II 1995-02-21
K934154 DISPOSABLE ASPIRATION/IRRIGATION CATHETER Neuro Navigational Corp. GWG Class II 1995-02-21
K941986 CUTANEOUS ELECTRODE Maxxim Medical GXY Class II 1995-02-21
K944487 ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES Prizm Medical, Inc. GXY Class II 1995-02-21
K934065 MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM Medtronic Vascular GZB Class II 1995-02-14
K915820 NEUROSEARCH-24 OR NRS-24 Lexicor Medical Technology, Inc. OLT Class II 1995-02-08
K920038 NEUROSEARCH-4 Lexicor HCC Class II 1995-02-08
K941799 DISPOSABLE CUTANEOUS ELECTRODES Bio-Logic Systems Corp. GXY Class II 1995-02-03
K941928 VARIOUS ELECTRODES Bio-Logic Systems Corp. GWN Class II 1995-02-03
K945572 CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-1352 Johnson & Johnson Professionals, Inc. GWG Class II 1995-02-03
K925750 RELAXOMAT Relaxomat, Inc. HCC Class II 1995-01-31
K942921 NEUROLINK EEG/EP/EMG SURFACE ELECTRODES Neuro Supplies, Inc. GXY Class II 1995-01-31

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