meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
33
Latest Decision
1996-09-20

Clearances · page 44 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K962503 GUGLIELMI DETACHABLE COIL Target Therapeutics HCG Class II 1996-09-20
K955577 ECLIPSE VERSION 3.0 Stellate Systems OLT Class II 1996-09-20
K960754 SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M Mecta Corp. QGH Class II 1996-09-18
K955012 MIZUHO RADIOLUCENT HEAD FRAME Mizuho America, Inc. HBL Class II 1996-09-12
K961376 SMART-TENS, MODEL 456 Bio-Medical Research, Ltd. GZJ Class II 1996-09-12
K962910 SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECTRODE - MODIFY Uni-Patch, Inc. GZJ Class II 1996-09-05
K961261 DYNATRON 525 Dynatronics Corp. LIH Class II 1996-09-05
K962097 VENTRICULAR CATHETER SET Cook, Inc. JXG Class II 1996-08-29
K961718 DEI MODEL 20 EEG Discovery Engineering Intl., Inc. HCC Class II 1996-08-27
K960435 PHOENIX CRX VALVE Phoenix Biomedical Corp. JXG Class II 1996-08-27
K961923 BERENSTEIN COIL Target Therapeutics HCG Class II 1996-08-15
K960656 GORE BURR HOLE COVER W. L. Gore & Associates, Inc. GXR Class II 1996-08-14
K954789 BRAINLAB HEADPINS Brainlab AG HAW Class II 1996-08-12
K960761 PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20 The Prometheus Group HCC Class II 1996-08-07
K961858 COSGROVE DEPTH ELECTRODE KIT(CDEK) Radionics, Inc. HAW Class II 1996-08-07
K962332 TENS/FES/NMES ELECTRODES Uni-Patch, Inc. GZJ Class II 1996-07-31
K961802 PRECLUDE SYNBLOC MEMBRANE W. L. Gore & Associates, Inc. GXO Class II 1996-07-31
K961639 LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM (LIGS) Elekta Instrument AB HAW Class II 1996-07-26
K955597 MEDI-TRACE DEFIB PADS Graphic Controls Corp. GYB Class II 1996-07-09
K954737 SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE J-Tech, Inc. HCC Class II 1996-07-03
K953339 BONESOURCE HYDROXYAPATITE CEMENT (HAC) Osteogenics, Inc. GXP Class II 1996-06-27
K961749 TRANSAMERICA ELECTRODE Transamerica Medical Systems GZJ Class II 1996-06-21
K960762 SYNERGY PLUS The Prometheus Group HCC Class II 1996-06-13
K961406 NEUROVIEW SCISSORS Neuro Navigational Corp. GWG Class II 1996-06-13
K961300 ASPIRATION/IRRIGATION CATHETER Neuro Navigational Corp. GWG Class II 1996-06-07
K961173 1.2MM REUSABLE NEUROVIEW ENDOSCOPE Neuro Navigational Corp. GWG Class II 1996-06-07
K961113 CNS INTERCHANGEABLE BIT CRANIAL DRILL Clinical Neuro Systems, LLC HBG Class II 1996-06-05
K954951 TAYLOR GENERAL PURPOSE MONITORING ELECTRODE Taylor Industries, Inc. GZJ Class II 1996-05-30
K960714 ISG VIEWING WAND I.S.G. Technologies, Inc. HAW Class II 1996-05-29
K960728 ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE) Neuromed, Inc. GZB Class II 1996-05-22
K960705 GUGLIELMI DETACHABLE COIL Target Therapeutics HCG Class II 1996-05-21
K960631 MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX Medtronic Vascular GZF Class II 1996-05-21
K960807 TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 Ohio Medical Instrument Co., Inc. GZT Class II 1996-05-17
K951951 FOCUS MODEL 795 UNIT Empi GZJ Class II 1996-05-17
K955291 DUALSCREEN Medtronic Vascular GZB Class II 1996-05-17
K960663 UNIVERSAL BITE BLOCK B&B Medical Technologies, Inc. JXL Class II 1996-05-17
K953434 MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS) Midas Rex Pneumatic Tools, Inc. HBB Class II 1996-05-16
K941553 MAGNES II BIOMAGNETOMETER Biomagnetic Technologies, Inc. OLX Class II 1996-05-16
K960969 GALVA 5-T Zimmer Elektromedizin GmbH GZJ Class II 1996-05-15
K961609 MODEL 1220, OR E-NET (54-62 CM) Physiometrix, Inc. GXY Class II 1996-05-10
K961120 MARKER SYSTEM FOR STEREOTAXIC NAVIGATION Howmedica Leibinger, Inc. HAW Class II 1996-05-10
K960470 NEURO-PATCH Aesculap, Inc. GXQ Class II 1996-05-10
K961141 EASY FLEX TENS/FES/MNS ELECTRODES 2 ROUND MODEL 8200/2X2 MODEL 8220 Uni-Patch, Inc. GXY Class II 1996-05-10
K944598 GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL Chester Labs, Inc. GYB Class II 1996-05-07
K944599 GRAHAM-FIELD CONDUCTIVE ECG SPRAY Chester Labs, Inc. GYB Class II 1996-05-07
K955397 MAYFIELD-ACCISS WORKSTATION Nomos Corp. HAW Class II 1996-04-30
K960873 MODEL 1210, MEDIUM E-NET Physiometrix, Inc. GXY Class II 1996-04-26
K960372 SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM Scanlan Intl., Inc. HCH Class II 1996-04-26
K960885 MODEL 1240, SMALL E NET Physiometrix, Inc. GXY Class II 1996-04-26
K952797 AT53 DUAL CHANNEL EMG Stoelting Co. HCC Class II 1996-04-17
K960732 HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500 Physiometrix, Inc. GXY Class II 1996-04-15
K932994 EVOKED POTENTIAL SYSTEM-1.0 Neuromedical Systems, Inc. GWF Class II 1996-04-15
K960792 DISPOSABLE NEUROVIEW INTRODUCER SHEATH Neuro Navigational Corp. GWG Class II 1996-04-11
K960273 HARMONIE SENSA Stellate Systems OMB Class II 1996-04-04
K955832 CORDIS VENTRICULAR ANTECHAMBER (VA) Cordis Corp. JXG Class II 1996-03-25
K950314 DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) Dantec Medical, Inc. GXZ Class II 1996-03-25
K955387 ISOTRON III, ISOTRON IV Excel Tech. , Ltd. LIH Class II 1996-03-22
K955860 MULTI III, IV Excel Tech. , Ltd. LIH Class II 1996-03-22
K941823 LEKSELL NEURO GENERATOR AND ACCESSORIES Elekta Instruments, Inc. GXD Class II 1996-03-22
K951903 EPIX XL TENS UNIT Empi GZJ Class II 1996-03-20
K924313 DIGITAL CONDUCTANCE METER The Jayms Co. HCC Class II 1996-03-14
K954394 AESCULAP VENTRICULOSCOPE SYSTEM Aesculap, Inc. GWG Class II 1996-03-07
K954938 DISPOSABLE NEUROVIEW OPERATING SHEATH Neuro Navigational Corp. GWG Class II 1996-03-07
K960170 ELECTROENCEPHALOGRAPH (EEG) Moberg Medical, Inc. GWF Class II 1996-03-01
K953568 CODMAN FIDUCIAL MARKER SYSTEM Codman & Shurtleff, Inc. HAW Class II 1996-02-29
K955351 NEUROVIEW COAXIAL BIPOLAR ELECTRODE Neuro Navigational Corp. GWG Class II 1996-02-29
K953257 ORALSENSOR Cycura Corp. HCC Class II 1996-02-27
K953124 MAYFIELD RADIOLUCENT 2000 SKULL CLAMP Ohio Medical Instrument Co., Inc. HBL Class II 1996-02-09
K955787 DIGITRACE HOME VIDEO SYSTEM New England Medical Instruments, Inc. OMB Class II 1996-02-09
K955598 CLARUS SPINEPEN MODEL 2126 Clarus Medical Systems, Inc. GWG Class II 1996-02-06
K952390 BRAINLAB STEROTATIC HEADRING Brainlab Med. Computersysteme GmbH HAW Class II 1996-02-02
K955257 SS102 DUAL CHANNEL SEP STIMULATOR Axon Systems, Inc. GWF Class II 1996-02-02
K954285 CONTOUR FLEX VALVES (REGULAR & SMALL) Radionics, Inc. JXG Class II 1996-01-26
K952294 NEURONET Computational Diagnostics, Inc. GWF Class II 1996-01-26
K954352 BITE BLOCK United States Endoscopy Group, Inc. JXL Class II 1996-01-25
K954954 CEEGRAPH TRAVELER AMBULATORY EEG RECORDER Bio-Logic Systems Corp. GWQ Class II 1996-01-25
K954276 STEALTHSTATION Surgical Navigation Technologies, Inc. HAW Class II 1996-01-24
K953356 EMG RECORDING RING ELECTRODE Chalgren Enterprises, Inc. GXY Class II 1996-01-22
K953361 EMG DISC RECORDING ELECTRODE Chalgren Enterprises, Inc. GXY Class II 1996-01-22
K954334 ACUPLUS S.H.P. Intl. Pty., Ltd. GZJ Class II 1996-01-22
K953354 EMG DISC RECORDING ELECTRODE Chalgren Enterprises, Inc. GXY Class II 1996-01-22
K954157 DG PORTABLE SYSTEM Medelec , Ltd. OLT Class II 1996-01-17
K952347 A-1050 EEG MONITOR Aspect Medical Systems, Inc. OLT Class II 1996-01-16
K944314 DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123 Bio-Logic Systems Corp. GXY Class II 1996-01-03
K946230 ENDURA REUSABLE TENS AND NMES ELECTRODES Selectivemed Components, Inc. GZJ Class II 1995-12-22
K954899 RIGID NEUROVIEW ENDOSCOPE Neuro Navigational Corp. GWG Class II 1995-12-19
K941558 MAYFIELD CHILD DISPOSABLE SKULL PIN Ohio Medical Instrument Co., Inc. HBL Class II 1995-12-06
K954699 BRAY RONGEUR Johnson & Johnson Professionals, Inc. HAE Class II 1995-12-06
K926094 PROTECTRODE SYSTEM The Electrode Store, Inc. GXZ Class II 1995-12-06
K930021 J TONGS Jerome Medical HAX Class II 1995-12-06
K952690 EMG DISC RECORDING ELECTRODE WITH PIN Chalgren Enterprises, Inc. GXY Class II 1995-12-06
K952908 EMG DISC RECORDING ELECTRODE WITH PIN Chalgren Enterprises, Inc. GXY Class II 1995-12-06
K954886 MODEL NOS. 7495 AND 501826 EXTENSIONS Medtronic Vascular GZB Class II 1995-11-27
K944600 GRAHAM-FIELD SALINE ELECTROLYTE GEL Chester Labs, Inc. GYB Class II 1995-11-20
K943449 NEUROLOGICAL DIAGNOSTIC DEVICES Henley Intl. GXY Class II 1995-11-15
K954127 BIOFEEDBACK DEVICE Verimed Holdings, Inc. HCC Class II 1995-11-14
K950986 NEUROREADER Artronics HCS Class II 1995-11-09
K946018 TENS-IT, FITTRONIC II, (MORE LATER) Ems, Inc. GZL Class II 1995-11-09
K953799 DG EXAMINER PLUS Medelec , Ltd. OLT Class II 1995-11-08
K953969 PRECLUDE DURA SUBSTITUTE W. L. Gore & Associates, Inc. GXQ Class II 1995-11-01

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