meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
31
Latest Decision
1991-11-22

Clearances · page 49 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K913532 TX 3 TENS MODIFIED Globalcare/Bay Medical Corp. GZJ Class II 1991-11-22
K912289 ULTIMA XS, MODIFICATION American Imex GZJ Class II 1991-11-22
K901704 RELIEF BAND (T.E.N.S. DEVICE) Maven Labs, Inc. GZJ Class II 1991-11-19
K904377 ELECTROCONDUCTIVE MEDIA Henley Intl. GYB Class II 1991-11-15
K914384 MEDICAL DESIGNS REUSABLE CARBON RUBBER ELECTRODE Medical Design & Manufacturing Corp. GXY Class II 1991-11-13
K912460 Q-TENS Quantitative Medicine, Inc. GZJ Class II 1991-11-13
K912463 MICRO-Q Quantitative Medicine, Inc. GZJ Class II 1991-11-13
K911779 HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED Target Therapeutics HCG Class II 1991-11-08
K913312 HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED Target Therapeutics HCG Class II 1991-11-08
K912775 SAPPHIRE 4ME EMG/EP SYSTEM Medelec Intl. Corp. GWF Class II 1991-11-08
K912178 BIO TENS 601, 606 AND 608 (3000) Skylark Device Co., Ltd. GZJ Class II 1991-10-25
K911144 MF-500, MODIFICATION Elcot, Inc. QGH Class II 1991-10-18
K912436 AM-PAK Cns, Inc. GWL Class II 1991-10-18
K905672 TEAM-MC Henley Intl. GZJ Class II 1991-10-15
K911814 AXION 5, MODIFICATION Ventura Medical Electronics GZJ Class II 1991-10-15
K913800 MEDA CROWN SERIES Medical Electronic Assn. GZJ Class II 1991-10-04
K910972 WALTER GRAPHTEK Inomed Medizintechnik GmbH GWQ Class II 1991-10-02
K911229 PHOENIX DIGITAL EEG SYSTEM Dantec Medical, Inc. GWQ Class II 1991-09-30
K912615 ROCHE COBAS ARGOS 5 DIFF Roche Diagnostic Systems, Inc. GZI Class II 1991-09-27
K911366 PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE Medical Design & Manufacturing Corp. GXY Class II 1991-09-27
K912005 CODMAN SKULL PINS (ADULT & CHILD), REUSABLE Codman & Shurtleff, Inc. HBL Class II 1991-09-19
K905059 HIGH SPEED MAGNETIC STIMULATOR Cadwell Laboratories, Inc. GWF Class II 1991-09-18
K911433 RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE Cordis Corp. JXG Class II 1991-09-16
K911812 ACRA-CUT WIRE PASS DRILL Acra Cut, Inc. HBE Class II 1991-09-10
K911723 CODMAN DISPOSABLE SKULL PINS Codman & Shurtleff, Inc. HBL Class II 1991-09-10
K911819 ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED Acra Cut, Inc. HBE Class II 1991-09-10
K905860 HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION Baxter Healthcare Corp JXG Class II 1991-09-10
K913170 CODMAN SKULL CLAMP Codman & Shurtleff, Inc. HBL Class II 1991-09-06
K912595 AXIOM ELECTROMYOGRAPH The Computerist, Inc. HCC Class II 1991-09-06
K910279 MCSEER/MICRO CONTROLLER SLD ST EEG EVENT RECORDER New England Medical Instruments, Inc. GWQ Class II 1991-09-04
K904743 LSI SYSTEM II M.S.P. , Ltd. LIH Class II 1991-09-04
K913373 GLOBALCARE ELECTRODE Globalcare Intl., Inc. GXY Class II 1991-08-29
K913522 SOLITENS MODIFIED Innovative Designer Products, Inc. GZJ Class II 1991-08-28
K911772 GARDNER PINS (ADULT & CHILD) Codman & Shurtleff, Inc. HBL Class II 1991-08-26
K911932 J105 JAMES SURGICAL SYSTEM I/A PACK O.R. Specialties, Inc. GZX Class I 1991-08-26
K913594 DYNEX IIIB, MODEL 89002026 Medtronic Vascular GZJ Class II 1991-08-23
K913051 SPECTRAL EEG MONITOR MODEL B500 Biometrak Corp. OLT Class II 1991-08-20
K910938 CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) Codman & Shurtleff, Inc. JXG Class II 1991-08-16
K910945 HORIZON 2000 EEG MONITORING OPTION Mennen Medical, Inc. GWQ Class II 1991-08-15
K903434 SELECT NEUROMUSCULAR STIMULATORS Medtronic Vascular GZI Class II 1991-08-09
K904926 SMART-EP Intelligent Hearing Systems GWJ Class II 1991-08-02
K911637 STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD Personal Products Co. HAD Class II 1991-08-02
K913233 CODMAN LHALO SPLIT RING RETRACTOR SYSTEM Codman & Shurtleff, Inc. GZT Class II 1991-07-31
K912011 CODMAN SKULL CLAMP Codman & Shurtleff, Inc. HBL Class II 1991-07-31
K912938 RHYTHM Stellate Systems GWS Class I 1991-07-30
K904294 QSI 9500 Quantified Signal Imaging, Inc. OLU Class II 1991-07-30
K911989 GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT. Somnitec, Inc. GXY Class II 1991-07-30
K912817 SOMNIMIC (R) Somnitec, Inc. LEL Class II 1991-07-26
K904883 OPTYX Baxter Healthcare Corp JXG Class II 1991-07-24
K905435 UNIQUANT Neuroconcepts, Inc. GWQ Class II 1991-07-22
K903734 ADVANTAGE EP Clark Davis Medical Systems, Inc. GWE Class II 1991-07-22
K911918 SWIVEL HORSESHOE HEADREST Codman & Shurtleff, Inc. HBM Class I 1991-07-17
K911917 CODMAN PEDIATRIC HORSESHOE HEADREST Codman & Shurtleff, Inc. HBM Class I 1991-07-17
K911069 VERSA-STIM ELECTRODE LINE MODIFIED Conmedcorp GXY Class II 1991-07-16
K910244 GLOBAL CARE MICRO II Globalcare Intl., Inc. GZJ Class II 1991-07-09
K911410 PS MEDICAL BUTTON VALVE Pudenz-Schulte Medical Research Corp. JXG Class II 1991-06-28
K905594 NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 Nihon Kohden America, Inc. GWK Class II 1991-06-28
K905569 ELECTRO-NERVE STIMULATOR TENS,MODEL SYSTEMS PLUS/A Biomedical Life Systems, Inc. GZB Class II 1991-06-27
K912348 SX90 (TM),MODEL 4800S Medical Devices, Inc. GZJ Class II 1991-06-24
K905526 AGARRELIEF 10 TRANSCUTANEOUS ELEC NERVE STIMULATOR Agar Ginosar Electronics GZJ Class II 1991-06-21
K910580 MICROSTIM 100 MODEL 2C Microstim, Inc. GZJ Class II 1991-06-20
K904328 VISTA POLYSOMNOGRAPHY COMPUTER SYSTEM Telediagnostic Systems, Inc. GWK Class II 1991-06-18
K905632 NICOLET MAPLELEAF SYSTEM Nicolet Instrument Corp. GWJ Class II 1991-06-07
K902226 MY-O-MATIC 5000I Monad Corp. GZJ Class II 1991-06-06
K905377 ELECTRO-NERVE STIMULATOR TENS MODEL SYSTEMS 2000/A Biomedical Life Systems, Inc. GZJ Class II 1991-06-04
K905570 ELECTRO-NERVE STIMULATOR TENS MODEL BIOMED 2000/A Biomedical Life Systems, Inc. GZJ Class II 1991-06-04
K904269 NEUROSEARCH-24 OR NRS-24 Lexicor Medical Technology, Inc. GWQ Class II 1991-06-04
K905230 ELECTRO-NEVE STIMULATOR TENS MODEL BIOMED PLUS/A Biomedical Life Systems, Inc. GZJ Class II 1991-06-04
K904388 POINTER F-3 TENS Oms Medical Supplies, Inc. GZJ Class II 1991-06-04
K902102 COM-TENS: A NEUROSTIMULATOR Apex Medical, Inc. GZJ Class II 1991-05-30
K904165 SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT Occupational Preventive Diagnostics, Inc. JXE Class II 1991-05-28
K905539 3M 6830 ELECTRODE 3M Healthcare GXY Class II 1991-05-28
K904889 TENS CONDUCTIVE MEDIA PAD Creative Design Systems, Inc. GYB Class II 1991-05-14
K902607 DANTEC MAGNETIC STIMULATOR MAG 2 (MAG 2) Dantec Medical, Inc. GWF Class II 1991-05-14
K904430 MENS FREEDOM MICRO Monad Corp. GZJ Class II 1991-05-13
K904235 MENS-O-MATIC 2000 Monad Corp. GZJ Class II 1991-05-13
K904234 MENS-O-MATIC I Monad Corp. GZJ Class II 1991-05-13
K904260 MENS-O-MATIC 3000 Monad Corp. GZJ Class II 1991-05-13
K904258 MICRO DERM Monad Corp. GZJ Class II 1991-05-13
K904288 MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS Monad Corp. GZJ Class II 1991-05-13
K904264 MODEL SW-103 SOLITANS STIMULATOR Medical Consultants Intl. , Ltd. GZJ Class II 1991-05-09
K905571 ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A Biomedical Life Systems, Inc. LIH Class II 1991-05-08
K903394 GLOBALCARE MICRO 11 AND MICROCARE (TENS) Globalcare Intl., Inc. GZJ Class II 1991-05-06
K910853 GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET Cordis Corp. JXG Class II 1991-04-24
K897132 PATHWAY II ELECTROMYOGRAPH The Prometheus Group HCC Class II 1991-04-18
K905372 MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002 Bio-Feedback Systems, Inc. HCC Class II 1991-04-12
K904763 MENTOR EEG SYSTEM Oxford Medilog, Inc. GWQ Class II 1991-04-10
K905373 MINIATURE TEMPERATURE TRAINER MODEL DT-002 Bio-Feedback Systems, Inc. HCC Class II 1991-04-10
K901540 MODEL RFG-3C RADIOFREQUENCY LESION GENERATOR Radionics, Inc. GXD Class II 1991-04-08
K904457 DIAL-AWAY PAIN R.F.P., Inc. GZJ Class II 1991-04-03
K910621 BLADES FOR SPINAL LAMINECTOMY RETRACTOR International Hospital Supply Co. GZT Class II 1991-04-01
K904514 STRUNG TELFA NON-ADHERENT SPONGE American Silk Sutures, Inc. HBA Class II 1991-03-27
K903161 MC II (TM), MODEL 7200S Medical Devices, Inc. GZJ Class II 1991-03-27
K896450 NEURO N 50 LESION GENERATOR Leibinger & Fischer , Ltd. GXD Class II 1991-03-19
K902550 EEG-5400 SERIES Nihon Kohden America, Inc. GWQ Class II 1991-03-19
K903577 DYNATRON 200 MICROCURRENT Dynatronics Corp. GZJ Class II 1991-03-15
K905596 NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST Neuromed, Inc. GZB Class II 1991-03-11
K905402 ANTIGENZ CHLAMYDIA Northumbria Biologicals , Ltd. GZB Class II 1991-03-11
K901883 STEREOTACTIC ONE MEDICAL APPLICATION SOFTWARE Stereotactic Image Systems, Inc. HAW Class II 1991-03-07
K903485 TITANIUM MESH Ruggles Corp. GWO Class II 1991-02-21

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