meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
42
Latest Decision
1998-07-06

Clearances · page 42 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K971252 SEVRAIN CRANIAL CLAMP Ikonos Corp. GXN Class II 1998-07-06
K974739 HAKIM PROGRAMMABLE VALVE SYSTEM Johnson & Johnson Professionals, Inc. JXG Class II 1998-07-01
K981213 UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I Radionics, Inc. HAW Class II 1998-07-01
K981015 PALI-TRODE Preferred Instruments GZL Class II 1998-06-16
K981046 MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118 Medtronic PS Medical JXG Class II 1998-06-16
K971214 KILOWIN Cadwell Laboratories, Inc. GWE Class II 1998-06-11
K973454 AD-TECH'S SPINAL ELECTRODE Ad-Tech Medical Instrument Corp GZL Class II 1998-06-10
K974583 DEEGLITE Grass-Telefactor Product Group OLV Class II 1998-06-09
K972881 CES VASCULAR OCCLUSION SYSTEM Cordis Neurovascular, Inc. HCG Class II 1998-06-04
DEN980001 DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND Cranial Technologies, Inc. MVA Class II 1998-05-29
K980866 MEDI-DX 7000 CPT WITH AMREX ELECTRODES Neuro-Diagnostic Assoc. GWF Class II 1998-05-20
K973789 NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC Norian Corp. GXP Class II 1998-05-18
K980584 ATLASPLAN Radionics, Inc. HAW Class II 1998-05-18
K980548 DURA-PATCH MODEL DP-XXX Bridger Biomed, Inc. GXQ Class II 1998-05-13
K971408 SEVRAIN CRANIAL CLAMP (SCC-200 SERIES) Ikonos Corp. GXN Class II 1998-05-12
K980373 ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE Ultramind International , Ltd. HCC Class II 1998-04-29
K965071 DETACHABLE SLICONE BALLOON (DSB) Target Therapeutics MZQ Class II 1998-04-21
K964488 DETACHABLE SILICONE BALLOON (DSB) Target Therapeutics MZQ Class II 1998-04-21
K974602 OPTICAL TRACKING SYSTEM (OTS) Radionics Software Applications, Inc. HAW Class II 1998-04-21
K980214 EXCEL NEURO WORKS Excel Tech. , Ltd. GWQ Class II 1998-04-21
K971400 MUSCLE RESPONSE MONITOR Enriching Your Life HCC Class II 1998-04-14
K973684 LEKSELL VIEWSCOPE, LEKSELL SURGISCOPE, LEKSELL FREEHAND Elekta Instrument AB HAW Class II 1998-03-31
K971914 TECA NCS ELECTRODE SYSTEM 2000 Medelec, Inc. D.B.A. Teca Corp. GXY Class II 1998-03-26
K963642 INCL II ENDOSCOPE Sofamor Danek USA,Inc. GWG Class II 1998-03-18
K974726 SUBDURAL DRAINAGE CATHETER KIT, SUBDURAL CATHETER Elekta Implants, SA JXG Class II 1998-03-18
K971740 AMPLAID MK12 Amplifon S.P.A. GWF Class II 1998-03-16
K980430 RADIONICS DISPOSABLE RF CANNULAE (SC-C, RFK-DB, RFK-DS) Radionics, Inc. GXI Class II 1998-03-16
K974206 SYNTHES CRANIAL SPRING CLIP (CSC) Synthes (Usa) GWO Class II 1998-03-16
K974708 GEMINI STANDARD AND MINI VALVES Neurocare Group JXG Class II 1998-03-10
K974718 PERSYST PRISM Persyst Development Corp. GWS Class I 1998-03-09
K974587 H2O Grass-Telefactor Product Group OLV Class II 1998-03-09
K974585 IF-727 INTERFERENTIAL STIMULATOR Skylark Device Co., Ltd. LIH Class II 1998-03-06
K973883 BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM Bio-Logic Systems Corp. GWQ Class II 1998-03-05
K972324 LEKSELL STEREOTACTIC SYSTEM Elekta Instrument AB HAW Class II 1998-03-02
K972244 NT2000 Bio-Medical Research, Ltd. GZJ Class II 1998-02-27
K980229 MSB TENS ELECTRODES (DISPOSABLE) Msb , Ltd. GXY Class II 1998-02-27
K974495 NEUROAMP EEG AMPLIFIER Neurocorp, Ltd. GWQ Class II 1998-02-26
K971708 PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE J & J Engineering, Inc. HCC Class II 1998-02-18
K980333 RELIEFBAND Woodside Biomedical, Inc. GZJ Class II 1998-02-18
K974514 EXTERNAL FUNCTIONAL NEUROMUSCULAR STIMULATOR Neuromotion, Inc. GZI Class II 1998-02-06
K972906 MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA) Medtronic Vascular GZB Class II 1998-02-06
K971799 PRECISION FLOW OSV II Elekta Implants, SA JXG Class II 1998-02-06
K974496 A-2000 EEG MONITOR WITH BIS Aspect Medical Systems, Inc. OLW Class II 1998-02-06
K972959 AMPLAID MK22 Amplifon S.P.A. GWF Class II 1998-02-06
K971756 MEDTRONIC MODEL 3998 LEAD Medtronic Vascular GZB Class II 1998-02-03
K973596 SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE Spacelabs Medical, Inc. OLW Class II 1998-02-03
K974208 TYTRON C-3000 Titronics Research & Development Co. HCS Class II 1998-02-03
K972157 EXCEL AV STIM 1000 Excel Tech. , Ltd. GWJ Class II 1998-01-30
K974119 DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM) Jack'S Electrodes GXZ Class II 1998-01-28
K974497 INTELECT Chattanooga Group, Inc. GZJ Class II 1998-01-23
K974187 STEALTHSTATION SYSTEM Surgical Navigation Technologies, Inc. HAW Class II 1998-01-21
K972857 SERVOTRONIC EC100 SYSTEM Medicon EG HBC Class II 1998-01-16
K971813 EMBLA Ferguson Medical OLV Class II 1998-01-16
K972332 AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM Aesculap, Inc. GXN Class II 1998-01-16
K974088 CODMAN INTRACRANIAL BOLT Johnson & Johnson Professionals, Inc. GWM Class II 1998-01-09
K973774 CODMAN HAKIM MICRO PRECISION VALVE Johnson & Johnson Professionals, Inc. JXG Class II 1997-12-29
K973706 DURA-GUARD-DURAL REPAIR PATCH Bio-Vascular, Inc. GXQ Class II 1997-12-24
K973537 PATHWAY ELECTROMYOGRAPH The Prometheus Group HCC Class II 1997-12-17
K973525 MAURICE WORLDWIDE SHUNT SYSTEM Integra Neurocare, LLC JXG Class II 1997-12-16
K970851 LYOPLANT DURA SUBSTITUTE(VARIOUS) Aesculap, Inc. GXQ Class II 1997-12-09
K973083 ULTRACELL NEURO SPONGES Ultracell Medical Technologies, Inc. HBA Class II 1997-12-09
K964622 MEDI-DX 7000 Neuro-Diagnostic Assoc. LLN Class I 1997-12-01
K970050 YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT) Aesculap, Inc. HCH Class II 1997-11-26
K974161 STEALTHSTATION SYSTEM Surgical Navigation Technologies, Inc. HAW Class II 1997-11-21
K971819 EPOCH 2000 NEUROLOGICAL WORKSTATION Axon Systems, Inc. GWF Class II 1997-11-20
K971329 CTF SYSTEMS INC, WHOLE-CORTEX MEG SYSTEM (WITH OPTIONAL EEG SUBSYSTEM) Ctf Systems, Inc. GWQ Class II 1997-11-20
K973277 CAROLINE GUIDE/DELIA LOCALIZER Surgical Solutions, Inc. HAW Class II 1997-11-17
K972994 EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMS Integra Neurocare, LLC JXG Class II 1997-11-03
K970162 NEUROLOGICAL ENDOSCOPE Richard Wolf Medical Instruments Corp. GWG Class II 1997-10-29
K972723 BIO TROL Mindmedia Labs, Inc. HCC Class II 1997-10-02
K972515 SENSOR AMPLIFIER Pro-Tech Services, Inc. GWL Class II 1997-10-02
K972487 EMG RETRAINER Chattanooga Group, Inc. HCC Class II 1997-09-26
K972631 ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER Ics Medical Corp. GWN Class II 1997-09-22
K972398 STEALTHSTATION PASSIVE INSTRUMENT OPTION Surgical Navigation Technologies, Inc. HAW Class II 1997-09-16
K972289 MIDAS REX MOTOR Midas Rex Pneumatic Tools, Inc. HBB Class II 1997-09-12
K972243 2D VOG - VIDEO-OCULOGRAPHY Sensomotoric Instruments, GmbH GWN Class II 1997-09-10
K964815 AP-4000, AIR PULSE SENSORY STIMULATOR Pentax Precision Instrument Corp. LLN Class I 1997-09-04
K972122 DREAM CATCHER Rest Technologies, Inc. GXY Class II 1997-08-29
K965244 Z TECH TRANSCUTANEOUS NEURAL STIMULATION Z Technologies, LLC GZJ Class II 1997-08-27
K972043 MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER Medtronic Vascular GZB Class II 1997-08-22
K964229 REGULUS NAVIGATOR Compass Intl., Inc. HAW Class II 1997-08-19
K961942 EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI Radionics, Inc. GYC Class II 1997-08-18
K970943 GUIDELINE SYSTEM Axon Instruments, Inc. GZL Class II 1997-08-18
K970436 E-READER Natural Herbal Products, Inc. GZO Class II 1997-08-15
K971867 ALICE 4R SYSTEM Healthdyne Technologies, Inc. OLV Class II 1997-08-13
K962951 MODEL HS-2 TENS DEVICE Technalithics Laboratories, Inc. GZJ Class II 1997-08-06
K961050 RELIEFBAND TENS UNIT (MODIFICATION) Maven Labs, Inc. GZJ Class II 1997-08-01
K965187 SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD Sparta Surgical Corp. GZJ Class II 1997-08-01
K971617 ENDOSCOPIC VENTRICULAR CATHETER Integra Neurocare, LLC JXG Class II 1997-07-31
K963195 WIRELESS EEG RECORDING SYSTEM MODEL W32 Cme Telemetrix, Inc. GYE Class II 1997-07-29
K971318 MM-1 MOVEMENT MONITOR Axon Instruments, Inc. GYD Class II 1997-07-28
K971511 RADIONICS CONTOUR FLEX VALVE, RADIONICS CONTOUR FLEX PLUS VALVE Radionics, Inc. JXG Class II 1997-07-24
K961817 B SMART MODEL 1 Koven Technology, Inc. LEL Class II 1997-07-23
K972202 DEEG-LITE Grass-Telefactor Product Group GWQ Class II 1997-07-23
K971437 BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000 Murray Electronics NYN Class II 1997-07-22
K964646 VIDEO EYE TRAKKER Micromedical Technologies, Inc. GWN Class II 1997-07-15
K964325 VISUALEYES: VIDEO EYE MONITOR Micromedical Technologies, Inc. GWN Class II 1997-07-15
K963208 NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS) Neurotron Medical JXE Class II 1997-07-14
K971675 SNT STEREOTACTIC LOCALIZATION SYSTEM Surgical Navigation Technologies, Inc. HAW Class II 1997-07-14
K970051 MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE Smith and Nephew Donjoy, Inc. HCC Class II 1997-07-10

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