meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
38
Latest Decision
1999-05-19

Clearances · page 41 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K990538 BRAINMASTER 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE Brainmaster HCC Class II 1999-05-19
K991429 DIAMOND II VALVE Phoenix Biomedical Corp. JXG Class II 1999-05-19
K990356 THE BAGNOLI-8 EMG SYSTEM Delsys, Inc. HCC Class II 1999-04-29
K990632 OPTICAL TRACKING SYSTEM (OTS) Radionics, Inc. HAW Class II 1999-04-29
K990333 MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 Medtronic PS Medical GWG Class II 1999-04-28
K991029 RAPIDFLAP CRANIAL CLAMP Walter Lorenz Surgical, Inc. GXN Class II 1999-04-23
K990214 FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM Surgical Navigation Technologies, Inc. HAW Class II 1999-04-22
K982053 EEG ELECTRODES MODEL 445 SERIES Class A Ent. GXY Class II 1999-04-20
K980903 RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT Radionics, Inc. JXG Class II 1999-04-19
K990129 TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR Therapy Link, Inc. LIH Class II 1999-04-12
K990370 MSB (ELECTRICAL STIMULATION) ELECTRODES (DISPOSABLE). (TENS/FES/NMES) Msb,Uk GXY Class II 1999-04-12
K990256 CRX WORLD SHUNT Phoenix Biomedical Corp. JXG Class II 1999-04-01
K990868 VIEWPOINT PASSIVE TOOL OPTION Philips Medical Systems (Cleveland), Inc. HAW Class II 1999-03-30
K990860 VIEWPOINT MICROSCOPE OPTION Philips Medical Systems (Cleveland), Inc. HAW Class II 1999-03-30
K983483 VASCULAR OCCLUSION SYSTEM Cordis Neurovascular, Inc. HCG Class II 1999-03-24
K983229 OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM Olympic Medical Corp. OMA Class II 1999-03-23
K983533 ACTIWATCH Mini-Mitter Co., Inc. GWQ Class II 1999-03-23
K983007 NEUROTUBE Neuroregen, LLC JXI Class II 1999-03-22
K984583 THE BIOPLATE SHUNT CONNECTOR Biomedics JXG Class II 1999-03-15
K984534 PRECLUDE ACUSEAL DURA SUBSTITUTE W. L. Gore & Associates, Inc. GXQ Class II 1999-03-15
K983228 BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000 Murray Electronics NYN Class II 1999-03-15
K984580 BIOSACA SYSTEM Biosys AB (Publ) OLV Class II 1999-03-12
K982173 BUZBEE Mwr Electronics Industrial Co. GZJ Class II 1999-03-11
K990326 OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII Radionics Software Applications, Inc. HAW Class II 1999-03-04
K982967 RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R Woodside Biomedical, Inc. GZJ Class II 1999-02-23
K980689 FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM Friddle'S Orthopedic Appliances, Inc. HAX Class II 1999-02-18
K984109 AESCULAP AXIAL CLIP APPLIER Aesculap, Inc. HCI Class II 1999-02-12
K983539 TRAJECTORY GUIDE, MODEL # TGX-XXX Image-Guided Neurologics, Inc. HAW Class II 1999-02-12
K984025 CARE TENS Care Rehab, Inc. GZJ Class II 1999-02-10
K990104 MEDTRONIC MODEL 7495 EXTENSION KIT Medtronic Vascular GZB Class II 1999-02-09
K984053 BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM Medtronic PS Medical JXG Class II 1999-02-04
K982324 VECTRA PRO MODELS 2 AND 4 Chattanooga Group, Inc. GZJ Class II 1999-02-01
K982321 VECTRA STIM MODELS 200 AND 400 Chattanooga Group, Inc. GZJ Class II 1999-02-01
K981480 PHILIPS EASYGUIDE Philips Medical Systems, Inc. HAW Class II 1999-01-28
K982819 ENDIUS SPINE ENDOSCOPE Endius, Inc. GWG Class II 1999-01-27
K983799 MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL Medtronic PS Medical GWM Class II 1999-01-26
K983670 STEALTHSTATION SYSTEM Surgical Navigation Technologies, Inc. HAW Class II 1999-01-14
K982570 SNN SCOUT I.S.G. Technologies, Inc. HAW Class II 1999-01-13
K983597 NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES Medicotest, Inc. GXZ Class II 1999-01-11
K983550 XYZ SYSTEM Bio-Monitoring International Corp. HCC Class II 1999-01-07
K984401 NEUROMAG VECTORVIEW Philips Medical Systems (Cleveland), Inc. OLX Class II 1998-12-30
K983741 EVERLAST NEUROSTIMULATION ELECTRODES 2X 2,MODEL # EL2020 Axelgaard Mfg. Co., Ltd. GXY Class II 1998-12-18
K983758 YASARGIL TITANIUM ANEURYSM CLIPS Aesculap, Inc. HCH Class II 1998-12-18
K983365 AESCULAP MINOP SYSTEM Aesculap, Inc. GWG Class II 1998-12-18
K982379 SUNDT SLIM-LINE ANEURYSM CLIP APPLIER Johnson & Johnson Professionals, Inc. HCI Class II 1998-12-18
K984245 NON-INVASIVE DYNAMIC REFERENCE FRAME (DRF) FOR OPTICAL TRACKING SYSTEM, MODEL OTS Radionics, Inc. HAW Class II 1998-12-18
K983331 MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 Medtronic PS Medical HCA Class II 1998-12-16
K983964 BATCH #6060 CONDUCTIVE GEL Skylark Device Co., Ltd. GYB Class II 1998-12-09
K974096 CRX DIAMOND VALVE Phoenix Biomedical Corp. JXG Class II 1998-12-08
K983397 STEALTHSTATION TREATMENT GUIDANCE PLAFFORM Surgical Navigation Technologies, Inc. HAW Class II 1998-12-04
K983072 AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 Nihon Kohden America, Inc. OLV Class II 1998-12-01
K981976 ACUTRON MENTOR MODEL 961 Microcurrent Research, Inc. GZJ Class II 1998-11-25
K983913 MODIFICATION TO BIO-LOGIC SLEEPSCAN Bio-Logic Systems Corp. OLV Class II 1998-11-25
K983009 BSM- BONE SUBSTITUTE MATERIAL Etex Corp. GXP Class II 1998-11-25
K981768 STEALTHSTATION TREATMENT GUIDANCE PLATFORM Surgical Navigation Technologies, Inc. HAW Class II 1998-11-23
K981820 NEUROMAP Radionics, Inc. GZL Class II 1998-11-20
K983669 OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS Radionics, Inc. HAW Class II 1998-11-18
K982902 PERIPHERAL NERVE STIMULATION Medtronic Vascular GZF Class II 1998-11-10
K983603 REFLECTIVE SPHERE STANDARD PROBE AND REFLECTIVE SPHERE DYNAMIC REFERENCE FRAME Radionics, Inc. HAW Class II 1998-11-10
K982837 KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS Karl Storz Endoscopy GWG Class II 1998-11-06
K983092 TRITON HUDSON CHUCK ATTACHMENT Mednext, Inc. HBB Class II 1998-11-06
K982410 SMP-PLUS,SX-PLUS,SX MODEL # 49XX SERIES 9 VOLT TENS DEVICE Rehabilicare, Inc. GZJ Class II 1998-11-06
K981508 VECTORVISION SPINE MODULE Brainlab AG HAW Class II 1998-10-29
K980410 SLE ELECTRODES AND ACCESSORIES Specialized Laboratory Equipment, Ltd. GXY Class II 1998-10-22
K982991 ANSPACH ACCESS CRANIAL PERFORATOR The Anspach Effort, Inc. HBF Class II 1998-10-21
K982479 EXCEL AMBULATORY EEG Excel Tech. , Ltd. GWQ Class II 1998-10-14
K980820 PHILIPS EASYGUIDE Philips Medical Systems, Inc. HAW Class II 1998-10-13
K982436 RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R Woodside Biomedical, Inc. GZJ Class II 1998-10-08
K982489 RFG-3C PLUS Radionics, Inc. GXD Class II 1998-10-05
K982359 NC-STAT Neurometrix, Inc. JXE Class II 1998-10-02
K982244 MAYFIELD ACCISS OPTICAL SYSTEM Ohio Medical Instrument Co., Inc. HAW Class II 1998-09-23
K982221 PREMIER AP American Imex GZJ Class II 1998-09-22
K982103 ULMER (VNG) VIDEO NYSTAGMOGRAPH Synapsys, Inc. GWN Class II 1998-09-11
K982702 VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD Camino Neurocare, Inc. GWM Class II 1998-09-10
K982040 MEDPOR SURGICAL GRANULE IMPLANTS Porex Surgical, Inc. GXP Class II 1998-09-08
K980686 AESCULAP HILAN MOTOR SYSTEM Aesculap, Inc. HBB Class II 1998-09-02
K981934 THE BAGNOLI-4 EMG SYSTEM Delsys, Inc. HCC Class II 1998-08-31
K961903 MAGELLAN Biosense, Ltd. HAW Class II 1998-08-24
K981969 ULTIMA BODY POSITION SENSOR Braebon Medical Corp. LEL Class II 1998-08-20
K981846 PARENCHYMAL BOLT PRESSURE MONITORING KIT Camino Neurocare, Inc. GWM Class II 1998-08-18
K981809 CAROLINE GUIDE Surgical Solutions, Inc. HAW Class II 1998-08-14
K964437 GB-1002 TENS WITH MASSAGE Skylark Device Co., Ltd. GZJ Class II 1998-08-14
K981844 SLEEP MANAGEMENT SYSTEM Rmp, Inc. HCC Class II 1998-08-07
K981686 STEALTHSTATION SYSTEM DIGITIZER CHANGE Surgical Navigation Technologies, Inc. HAW Class II 1998-08-07
K981805 POS T-7000 Pos Technologies, Inc. HCS Class II 1998-08-07
K980477 IMAGE VUE EEG Sam Technology, Inc. OLX Class II 1998-08-06
K981684 STEALTHSTATION TREATMENT GUIDANCE PLATFORM Surgical Navigation Technologies, Inc. HAW Class II 1998-08-06
K982364 WIRELESS STANDARD PROBE, DYNAMIC REFERENCE FRAME (DRF) Radionics, Inc. HAW Class II 1998-08-05
K982282 DURA-GUARD - DURAL REPAIR PATCH Bio-Vascular, Inc. GXQ Class II 1998-07-30
K973978 MICRO II MICROCURRENT TENS Apex Medical Corp. GZJ Class II 1998-07-29
K973979 MULTI-STIM TENS, AP-101081T Apex Medical Corp. GZJ Class II 1998-07-29
K973980 ACU-STIM TENS, AP-101082T Apex Medical Corp. GZJ Class II 1998-07-29
K971340 OLYMPUS NEURO ENDOSCOPE Olympus Optical, Co. GWG Class II 1998-07-29
K982351 LUNA Stellate Systems OLT Class II 1998-07-29
K972846 BMC RF CANNULA Baylis Medical Co., Inc. GXI Class II 1998-07-17
K980778 HAKIM MICRO PROGRAMMABLE VALVE SYSTEM Johnson & Johnson Professionals, Inc. JXG Class II 1998-07-17
K981405 SYNERGY LT Oxford Instruments, Plc. GWF Class II 1998-07-16
K974748 NEUROMETRIC ANALYSIS SYSTEM Nxlink, Ltd. OLU Class II 1998-07-10
K972750 TAKA ANEURYSM CLIP V. Mueller Neuro/Spine HCH Class II 1998-07-09
K981315 NAVITRACK Orthosoft, Inc. HAW Class II 1998-07-09

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