meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
33
Latest Decision
2000-01-24

Clearances · page 40 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K993622 NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY Alpha Omega , Ltd. GZL Class II 2000-01-24
K993417 GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC) Boston Scientific, Target HCG Class II 2000-01-21
K993415 GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1 Boston Scientific, Target HCG Class II 2000-01-21
K993418 FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL Boston Scientific, Target HCG Class II 2000-01-21
K993824 MSAS PROFESSIONAL Biomeridian, Int. GZO Class II 2000-01-20
K993239 STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX Stryker Corp. HAW Class II 2000-01-18
K994330 ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076 Aspect Medical Systems, Inc. GXY Class II 2000-01-18
K992916 BRAINLAB STEREOTACTIC ARC Brainlab HAW Class II 2000-01-11
K992911 MAGSTIM RAPID Magstim Corporation US GWF Class II 2000-01-07
K991959 PSI TITANIUM ANEURYSM CLIP V. Mueller Neuro/Spine HCH Class II 2000-01-06
K992927 STEALTHSTATION TREATMENT GUIDANCE PLATFORM Surgical Navigation Technologies, Inc. HAW Class II 1999-12-29
K994149 MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO. Bio-Logic Systems Corp. GWJ Class II 1999-12-27
K993851 SODEM PERFORATOR DRIVE Sodemsystems HBB Class II 1999-12-27
K991139 GUGLIELMI DETACHABLE (GDC) Boston Scientific, Target HCG Class II 1999-12-22
K994175 MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE Sodemsystems HBB Class II 1999-12-21
K993673 SNN FLUORO NAVIGATION SYSTEM I.S.G. Technologies, Inc. HAW Class II 1999-12-21
K993130 ULTRA-GARMENT ELECTRODE Newwave Medical, LLC GXY Class II 1999-12-17
K993202 EIM-107 PREP-CHECK General Devices GZO Class II 1999-12-17
K993539 DCI ENDOSCOPE KARL STORZ Endoscopy-America, Inc. GWG Class II 1999-12-15
K983907 RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R Woodside Biomedical, Inc. GZJ Class II 1999-12-09
K991706 VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE Stryker Corp. HAW Class II 1999-12-07
K993708 BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG Biomagnetic Technologies, Inc. OLX Class II 1999-12-03
K993501 3D1 MICROPOSITIONING HEADSTAGE Scientific Tools, Inc. HAW Class II 1999-11-22
K993823 MED-4000 Micro Current Technology, Inc. GZJ Class II 1999-11-19
K990290 CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER Biomet, Inc. GXP Class II 1999-11-18
K993177 SABRE Sle Limited GWJ Class II 1999-11-16
K992709 1818 TENS UNIT 138 Medical Supplies, Inc. GZJ Class II 1999-11-09
K991054 BRAVO MULTI-MODALITY SYSTEM Nicolet Biomedical, Inc. GWQ Class II 1999-11-03
K990683 AXON MP-1 MICROPOSITIONER Axon Instruments, Inc. HAW Class II 1999-11-03
K990788 AD-TECH'S FORAMEN OVALE ELECTRODE Ad-Tech Medical Instrument Corp GZL Class II 1999-11-02
K992843 THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F Ohio Medical Instrument Co., Inc. HAW Class II 1999-11-02
K992796 ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 Image-Guided Neurologics, Inc. HCA Class II 1999-10-25
K991853 INTERACOUSTICS EP 15 ABR STAND ALONE UNIT Idem (Int'L Dist. of Electronics For Medicine) GWJ Class II 1999-10-25
K992269 VENTIL-A ORAL PROTECTOR Somatics, Inc. JXL Class II 1999-10-25
K990793 ACCUGUIDE MUSCLE INJECTION MONITOR Medtronic Xomed GXZ Class II 1999-10-22
K992898 THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM Bright Medical Instruments GZT Class II 1999-10-21
K992591 CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS Codman & Shurtleff, Inc. GWM Class II 1999-10-15
K992410 ACTITRAC Individual Monitoring Systems, Inc. GWQ Class II 1999-10-15
K992742 NEUROFAX, MODEL EEG-1100A Nihon Kohden America, Inc. OLV Class II 1999-10-14
K991256 VIEWPOINT ENT/ORTHOPEDIC OPTION Philips Medical Systems (Cleveland), Inc. HAW Class II 1999-10-08
K992882 LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT Elekta Instrument AB HAW Class II 1999-09-24
K992946 RENEW RECEIVER Advanced Neuromodulation Systems GZB Class II 1999-09-24
K990660 NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX Nmt Neurosciences Implants S.A. JXG Class II 1999-09-23
K991398 BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT Stryker Leibinger GXP Class II 1999-09-22
K991399 RADIONICS MICROELECTRODE KIT Radionics, Inc. GXI Class II 1999-09-21
K991045 MINI-LOGGER SERIES 2000 Mini-Mitter Co., Inc. GWK Class II 1999-09-21
K983410 @ TARGET Brainlab AG HAW Class II 1999-09-17
K992129 PHAZX VLD-100 Phazx Systems, Inc. GZO Class II 1999-09-17
K983097 TENS/FES/NMES ELECTRODES Uni-Patch, Inc. GXY Class II 1999-09-17
K992807 BIO-LOGIC EVOKED POTENTIAL FOR ABAER I Bio-Logic Systems Corp. GWJ Class II 1999-09-14
K992194 CORTICAL MAPPING UNIT, MODEL CMU Ad-Tech Medical Instrument Corp GYC Class II 1999-09-13
K992721 COSMAN ROBERT WELLS FUNCTIONAL PROBE MICRODRIVE Radionics, Inc. HAW Class II 1999-09-10
K992379 RADIONICS XDC EXTERNAL VENTRICULAR CATHETER Radionics, Inc. JXG Class II 1999-09-08
K991899 NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES Nihon Kohden America, Inc. GWF Class II 1999-09-01
K991989 MITAKA POINT SETTER Mitaka USA, Inc. GWG Class II 1999-08-27
K992283 ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY Airsep Corp. OLV Class II 1999-08-27
K992304 NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX Image-Guided Neurologics, Inc. HAW Class II 1999-08-27
K992457 SNN SYSTEM WITH OLIVIER DOUBLE CHUCK SUPPORT ARM OPTION Surgical Navigation Specialists, Inc. HAW Class II 1999-08-27
K990230 ELECTRO-NERVE STIMULATOR TENS, MODEL LX Biomedical Life Systems, Inc. GZJ Class II 1999-08-19
K992313 XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16 Excel Tech. , Ltd. GWF Class II 1999-08-19
K991771 DIGITAL RING ELECTRDE Neuro Supplies, Inc. GXY Class II 1999-08-18
K991770 CUTANEOUS (GROUND) ELECTRODE Neuro Supplies, Inc. GXY Class II 1999-08-18
K991772 CUTANEOUS (DISC) ELECTRODE Neuro Supplies, Inc. GXY Class II 1999-08-18
K991769 CUTANEOUS (BAR) ELECTRODE Neuro Supplies, Inc. GXY Class II 1999-08-18
K991893 PARALLAX TRACER RADIOPAQUE PARTICLES Parallax Medical, Inc. MYU Class II 1999-08-13
K992439 NORODYN 8000 SEMG SYSTEM, ND-8000 Myotronics-Noromed, Inc. HCC Class II 1999-08-13
K992473 EXPRESSEYE Optomotor Laboratories GWN Class II 1999-08-12
K990907 REMOTE INTRODUCER, MODEL PI-1000 Image-Guided Neurologics, Inc. HAW Class II 1999-08-12
K992291 H20- TETHERED OPTION Grass-Telefactor Product Group OLV Class II 1999-08-06
K991903 EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) Excel Tech. , Ltd. GWE Class II 1999-08-04
K991642 EYE TRAK TM, COMPUTERIZED ELECTRONYSTAGMOGRAPH (ENG), MODEL ETV-XXXX Bertec Corp. GWN Class II 1999-08-03
K991625 KOMET XK-95 PERFORATOR MOTOR (MI-102) Komet Medical HBB Class II 1999-07-30
K991497 ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM Ics Medical Corp. GWN Class II 1999-07-28
K991446 BIOSACA SYSTEM, MODEL 800 Biosys AB (Publ) OLV Class II 1999-07-23
K992000 SYNTHES CRANIAL FLAP TUBE CLAMP Synthes (Usa) GXN Class II 1999-07-20
K991636 ELEKTA STEREOTACTIC GUIDE Elekta Instrument AB HAW Class II 1999-07-20
K991860 SYNTHES CRANIAL FLAP TWIST CLAMP Synthes (Usa) GXN Class II 1999-07-20
K980380 NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS Diametrics Medical, Ltd. GWM Class II 1999-07-14
K991267 SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A Ohio Medical Instrument Co., Inc. HAW Class II 1999-07-12
K991900 XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 Excel Tech. , Ltd. OLV Class II 1999-07-12
K991222 CODMAN MICROSENSOR VENTRICULAR CATHETER KIT Johnson & Johnson Professionals, Inc. GWM Class II 1999-07-09
K983764 VIEWPOINT TOOLS- STERRAD Philips Medical Systems (Cleveland), Inc. HAW Class II 1999-07-08
K982180 DURAGEN DURAL GRAFT MATRIX Integra Lifesciences Corp. GXQ Class II 1999-07-06
K991081 FRAMELESS NEUROMATE Integrated Surgical Systems, Inc. HAW Class II 1999-06-25
K991784 RENEW LEAD EXTENSION Advanced Neuromodulation Systems GZB Class II 1999-06-24
K991012 SIEMENS INFINITY EEG POD Siemens Medical Solutions USA, Inc. OLT Class II 1999-06-24
K984298 Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI Z-Kat, Inc. HAW Class II 1999-06-23
K991033 ACTIWATCH-SCORE Mini-Mitter Co., Inc. GWQ Class II 1999-06-23
K991199 BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150 Biomed Products GXY Class II 1999-06-22
K982096 DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO Rapid Mfg. Co. GXY Class II 1999-06-18
K991077 MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000) Microrecording Systems Consultants, LLC GZL Class II 1999-06-09
K982961 MEDIPOINT Medipoint , Ltd. GZJ Class II 1999-06-07
K990202 SUGITA TITANIUM ANEURYSM CLIP Mizuho America, Inc. HCH Class II 1999-06-04
K990778 INSIGHT MILLENNIUM Fasstech HCC Class II 1999-06-03
K990469 LAMITRODE LEADS Advanced Neuromodulation Systems GZB Class II 1999-06-03
K991069 KSEA NEURO-FIBERSCOPE KARL STORZ Endoscopy-America, Inc. GWG Class II 1999-06-03
K984035 XK-95 HIGH SPEED MOTOR DRILL SYSTEM Komet Medical HBE Class II 1999-06-03
K981246 BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730) Integra Neurocare, LLC JXG Class II 1999-05-26
K990522 WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS Lamont Medical, Inc. OLV Class II 1999-05-19
K983831 VECTORVISION2 Brainlab AG HAW Class II 1999-05-19

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