meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
32
Latest Decision
1994-02-03

Clearances · page 47 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K932948 MEDTRONIC MODEL 3625 SCREENER SYSTEM Medtronic Vascular GZB Class II 1994-02-03
K934050 TOPOGRAPHIC BRAIN MAPPING OPTION Biosound, Inc. OLT Class II 1994-02-03
K933951 VIDEO EEG OPTION MODIFICATION Esaote Biomedica Spa GWQ Class II 1994-02-03
K930242 INTRODE INT-8 Neuromed, Inc. GZB Class II 1994-02-02
K931108 EZ GRIP REUSABLE TENS/NMES ELECTRODES Advanced Adhesives GZJ Class II 1994-02-01
K932611 NEUROMUSCULAR STIMULATOR Myo/Kinetic Systems, Inc. GZJ Class II 1994-01-31
K931715 PURECARE AT-903 T.E.N.S. Fuching Enterprise Co., Ltd. GZJ Class II 1994-01-27
K932849 PMI TENS ELECTRODE Pepin Mfg., Inc. GZJ Class II 1994-01-27
K934599 SANDMAN Melville Software , Ltd. OLV Class II 1994-01-27
K933978 NEDBOND EJECTOR KERRISON RONGEUR Redmond Neurotechnologies Corp. HAE Class II 1994-01-12
K934289 MAYFIELD RADIOLUCENT SKULL CLAMP Ohio Medical Instrument Co., Inc. HBL Class II 1994-01-07
K931426 NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODE Medicotest, Inc. GXY Class II 1993-12-21
K931430 CUTANEOUS ELECTRODE Medicotest, Inc. GXY Class II 1993-12-21
K933894 DISPOSABLE PERFORATOR Codman & Shurtleff, Inc. HBF Class II 1993-12-10
K933814 PHOTOSTRESS RECOVERY TESTER Storz Instrument Co. GXY Class II 1993-12-08
K925735 EEG ANALYZER Bio-Scan, Inc. GWS Class I 1993-12-03
K924977 CODMAN LASER NEUROENDOSCOPE Codman & Shurtleff, Inc. GWG Class II 1993-11-22
K934391 V/P AND L/P CATHETER PASSERS Radionics, Inc. GYK Class I 1993-11-19
K926424 CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON Radionics, Inc. GYC Class II 1993-11-19
K931923 DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) Dantec Medical, Inc. GWF Class II 1993-11-09
K923330 THE WESTERN CORTICAL ELECTRODE ARRAY University Hospital (London) Development Corp. GYC Class II 1993-11-09
K914866 ITC CONTOUR EMBOLI, MODIFICATION Interventional Therapeutics Corp. HCG Class II 1993-11-09
K922052 TSA 2001 THERMAL SENSORY ANALYZER Medoc Corp. LQW Class I 1993-10-21
K914925 MEDAC SYSTEM/3 Davicon, Inc. HCC Class II 1993-10-21
K930080 E*NET NEUROMONITORING SYSTEM Physiometrix, Inc. GWQ Class II 1993-10-19
K932320 NEUTRALIZER Smith and Nephew Donjoy, Inc. GZJ Class II 1993-10-06
K932860 MAYFIELD ADULT DISPOSABLE SKULL PIN Ohio Medical Instrument Co., Inc. HBL Class II 1993-09-28
K932807 MAYFIELD* A-2000 SKULL CLAMP Ohio Medical Instrument Co., Inc. HBL Class II 1993-09-28
K922838 NORODYN 2000 ELECTROMYOGRAPH Noromed, Inc. HCC Class II 1993-09-22
K931973 DISPOSABLE PEEL-AWAY INTRODUCER SHEATH Neuro Navigational Corp. GWG Class II 1993-09-14
K930606 PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER Pudenz-Schulte Medical Research Corp. GYK Class I 1993-09-10
K933244 DISPOSABLE GRASPING FORCEP Neuro Navigational Corp. GWG Class II 1993-09-10
K924606 BREMER IMAGING TONGS-MRI MODEL Bremer Medical, Inc. HAX Class II 1993-09-09
K926516 DANTEC MAGNETIC STIMULATOR MAGPRO Dantec Medical, Inc. GWF Class II 1993-08-31
K925466 CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON Uni-Patch, Inc. GYB Class II 1993-08-26
K932273 CORDIS TUNNELER Cordis Corp. GYK Class I 1993-08-23
K925952 MEDTRONIC MODEL 3990 PNS LEAD Medtronic Vascular GZF Class II 1993-08-20
K931991 GNOMOS STEREOTACTIC SYSTEM W/ NONINVASIVE FIXATION Nomos Corp. HAW Class II 1993-08-20
K931925 TPK CUTANEOUS ELECTRODE Staodyne, Inc. GXY Class II 1993-08-16
K932402 MODIFICATION TO GHAJAR GUIDE TWIST DRILL Neurodynamics, Inc. HBG Class II 1993-08-05
K926349 PROBLOC INSULATED NEEDLES Life-Tech Intl., Inc. GXZ Class II 1993-07-29
K931989 VENTRI-CATH Gesco Intl., Inc. JXG Class II 1993-07-21
K915864 MONOTRODE CUTANEOUS ELECTRODE Henley Intl. GXY Class II 1993-07-21
K922393 EMITENS ELECTRODES Electronic Monitors, Inc. GXY Class II 1993-07-21
K932169 MICROSURGICAL INSTRUMENTS American Russian Medical Services, Inc. GZX Class I 1993-07-20
K924242 DISPOSABLE PERFORATOR Codman & Shurtleff, Inc. HBF Class II 1993-07-08
K930264 MATRIX ELECDT & VACUPULLS Matrix Electromedical, Inc. LIH Class II 1993-06-29
K924179 EEG MODEL 24/32 Lama Engineering, Inc. GWQ Class II 1993-06-22
K931428 CADWELL 6200 A Cadwell Laboratories, Inc. GWF Class II 1993-06-22
K931570 COM-TENS (SINGLE MODE) Ems Dist. GZJ Class II 1993-06-18
K931424 MAXIMA I Staodyne, Inc. GZJ Class II 1993-06-04
K926326 MICROCARE(TM) American Imex GZJ Class II 1993-06-01
K924473 DISPOSABLE THERAPY ELECTRODE Zimmer Elektromedizin GmbH GXY Class II 1993-05-19
K923970 INTEGRITY 2 Medrotech Corp. GZJ Class II 1993-05-18
K922202 K-STIM CLEAR Katecho, Inc. GZJ Class II 1993-05-17
K921138 NICOLET ULTRASOM ACQUISITION STATION Nicolet Instrument Corp. GWQ Class II 1993-05-14
K930865 STAODYN MAXIMA III Staodyne, Inc. GZJ Class II 1993-05-13
K925648 SMART-SCREENER (AUDITORY) Intelligent Hearing Systems GWJ Class II 1993-05-11
K925821 COMFORTRON M. D. Supply, Inc. GZJ Class II 1993-05-07
K921319 NEUROMED MODEL OCA-30 OCTODE AND MODEL SCA-30 Neuromed, Inc. GZB Class II 1993-05-05
K925838 TELEFACTOR D/EEG-32 Grass-Telefactor Product Group GWQ Class II 1993-04-30
K924333 THE DAVIS DISPOSABLE PROTECTIVE SPLINT Ora-Gard, Inc. JXL Class II 1993-04-23
K924226 OJEMANN CORTICAL STIMULATOR Radionics, Inc. GYC Class II 1993-04-21
K925876 ITC BUNJI PLATINUM EMBOLIZATION COIL Interventional Therapeutics Corp. HCG Class II 1993-04-15
K930221 CAMINO VENTRICULAR TRANSDUCER ACCESSORY Camino Laboratories, Inc. GWM Class II 1993-04-15
K930222 CAMINO VENTRICULAR ACCESS DEVICE Camino Laboratories, Inc. JXG Class II 1993-04-15
K915663 TENS PRO 900 Acuhealth (Usa) Pty. , Ltd. GZJ Class II 1993-04-15
K926048 CLARUS ENDOSCOPIC BALL PROBE Clarus Medical Systems, Inc. GZX Class I 1993-04-07
K924304 BITE BLOCK United States Endoscopy Group, Inc. JXL Class II 1993-04-06
K913412 PS MEDICAL CSF-ACCESS DEVICE Pudenz-Schulte Medical Research Corp. JXG Class II 1993-03-30
K925687 INTERFERENTIAL STIMULATOR MODEL IMF4150/A Biomedical Life Systems, Inc. LIH Class II 1993-03-29
K926574 MODEL 330 SCREENING AUDIO METER, MODIFIED Virtual Corp. GWJ Class II 1993-03-29
K925523 ITC BUNJI PLATINUM EMBOLIZATION COIL Interventional Therapeutics Corp. HCG Class II 1993-03-23
K924723 CADWELL SIERRA Cadwell Laboratories, Inc. GWF Class II 1993-03-23
K925686 THERA PULSE A ELECTRO NERVE STIMULATOR Biomedical Life Systems, Inc. GZJ Class II 1993-03-18
K924522 MEDTRONIC MODEL 3080 PISCES-QUAD LEAD Medtronic Vascular GZB Class II 1993-03-18
K923931 MEDTRONIC MODEL 3487A PISCES-QUAD LEAD Medtronic Vascular GZB Class II 1993-03-18
K930229 CLINICAL NEURO SYSTEMS CRANIAL DRILL Clinical Neuro Systems, LLC HBE Class II 1993-03-16
K924127 DANTEC EVOLUTION Dantec Medical, Inc. GWF Class II 1993-03-10
K923894 YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH Biosound, Inc. GWQ Class II 1993-03-10
K924666 INTELECT IFC2 Chattanooga Group, Inc. LIH Class II 1993-03-05
K924961 HMP 4000 INTERFERENTIAL STIMULATOR Hmp 4000, Inc. LIH Class II 1993-02-25
K925881 DISPOSABLE BIOPSY FORCEP Neuro Navigational Corp. GWG Class II 1993-02-19
K923479 DISPOSABLE NEUROVIEW ENDOSCOPE Neuro Navigational Corp. GWG Class II 1993-02-19
K923789 MAYFIELD ADULT DISPOSABLE SKULL PIN Ohio Medical Instrument Co., Inc. HBL Class II 1993-02-12
K925706 REUSABLE FINGER CLIP RECORDING ELECTRODE Chalgren Enterprises, Inc. GXY Class II 1993-02-10
K924490 MASTERSTIM I-2 Health Care Assoc. LIH Class II 1993-02-05
K923860 THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR Biosound, Inc. GWQ Class II 1993-02-04
K925197 PSI 220 DUAL EMG Fasstech HCC Class II 1993-02-02
K925898 MODEL 19 STIMULATOR, NERVE, TRANSCUTANEOUS Staodyne, Inc. GZJ Class II 1993-01-28
K920674 ELECTROLINK Kold Products GXY Class II 1993-01-28
K923950 THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH Biosound, Inc. GWQ Class II 1993-01-26
K925729 SD-602 SD MODE 11, SD-603 SD MOD 111 Skylark Device Co., Ltd. GZJ Class II 1993-01-22
K924319 DYNATRON 400 Dynatronics Corp. LIH Class II 1993-01-14
K914600 NEUROLOGICAL SPONGE I M, Inc. HBA Class II 1992-12-30
K923646 CODMAN ENDOFLEX GRASPING AND BIOPSY FORCEPS Codman & Shurtleff, Inc. GWG Class II 1992-12-21
K924600 INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS Cordis Corp. JXG Class II 1992-12-10
K921946 TUM-E-VAC BITE BLOCK Ethox Corp. JXL Class II 1992-12-09
K915741 DISPOSABLE MONOPLAR MEDDLE ELECTRODES Dantec Medical, Inc. GXE Class I 1992-12-08
K923043 SPECTRAL EEG MONITOR MODEL A1000 Aspect Medical Systems, Inc. OLT Class II 1992-12-03

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