meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
34
Latest Decision
1997-07-10

Clearances · page 43 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K965079 SOMNITOR 32K SLEEP ACTIVITY MONITOR Neurim Pharmaceuticals, Ltd. LEL Class II 1997-07-10
K964172 MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL Medtronic Vascular GZB Class II 1997-07-03
K943535 MODEL ME 300 MUSCLE TESTER Regulatory Strategies, Inc. HCC Class II 1997-06-25
K964923 CODMAN LUMBAR DRAINAGE CATHETER KIT Johnson & Johnson Professionals, Inc. JXG Class II 1997-06-25
K971331 SATELLITE Nicolet Biomedical, Inc. GWQ Class II 1997-06-25
K940954 SYNAPTIC 3000 The Synaptic Corp. GZJ Class II 1997-06-20
K965065 TECA. MILLENNIUM Medelec , Ltd. GWF Class II 1997-06-20
K971247 SNT DISPOSABLE BIOPSY NEEDLE Surgical Navigation Technologies, Inc. HAW Class II 1997-06-16
K970983 PERITONEAL/CARDIAC CATHETER Integra Neurocare, LLC JXG Class II 1997-06-13
K970578 RADIONICS BURR HOLE VALVE Radionics, Inc. JXG Class II 1997-06-04
K970865 ISG FAMILY OF VIEWING WANDS I.S.G. Technologies, Inc. HAW Class II 1997-06-04
K964801 OPTICAL TRACKING SYSTEM (OTS) Radionics Software Applications, Inc. HAW Class II 1997-06-02
K970942 MODEL 1320, NEUROLINK II NEUROMONITORING SYSTEM Physiometrix, Inc. GWQ Class II 1997-06-02
K970672 CRYSTAL-EEG MODEL 10 (MODEL 10) Cleveland Medical Devices, Inc. OMC Class II 1997-05-22
K962939 VECTORVISION Brainlab, Inc. HAW Class II 1997-05-22
K963202 MEGA ME 3000 PROFESSIONAL MUSCLE TESTER Mega Electronics , Ltd. HCC Class II 1997-05-19
K970658 LUMBAR DRAINAGE ACCESSORY KIT Integra Neurocare, LLC JXG Class II 1997-05-19
K970604 VIEWPOINT - 3.0 SOFTWARE Philips Medical Systems (Cleveland), Inc. HAW Class II 1997-05-19
K970951 GRASS BRAINWAVE SOFTWARE Astro-Med, Inc. OLV Class II 1997-05-19
K970703 GALILEO HALLEY Biosound Esaote, Inc. GWQ Class II 1997-05-19
K970659 DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER Telediagnostic Systems, Inc. GYE Class II 1997-05-16
K970639 NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K Medicotest, Inc. GXY Class II 1997-05-15
K970694 MODEL 1700, HYDRO PREP Physiometrix, Inc. GYB Class II 1997-05-14
K964644 AD-TECH'S DEPTH ELECTRODE Ad-Tech Medical Instrument Corp GZL Class II 1997-05-09
K970426 VALUETRODE Axelgaard Mfg. Co., Ltd. GXY Class II 1997-05-09
K970587 AD-TECH SUBDURAL ELECTRODE Ad-Tech Medical Instrument Corp GYC Class II 1997-05-09
K963256 NEUROMATE STEREOTACTIC SYSTEM Integrated Surgical Systems, S.A. HAW Class II 1997-05-09
K962317 MAGNES 2500 WH BIOMAGNETOMETER Biomagnetic Technologies, Inc. OLY Class II 1997-05-07
K962807 AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES American Surgical Sponges HBA Class II 1997-05-02
K970429 BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T Apex Medical Corp. GZJ Class II 1997-04-29
K970418 PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX) Pmt Corp. GZL Class II 1997-04-29
K953982 SIMPLEX TENS Armstrong Industries, Inc. GZJ Class II 1997-04-25
K970180 VSA 3000 VIBRATORYN SENSORY ANALYZER Eare Consulting Service LLN Class I 1997-04-25
K965139 SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM Carl Zeiss, Inc. HAW Class II 1997-04-23
K970328 ULTRACELL NEURO SPONGES Ultracell Medical Technologies, Inc. HBA Class II 1997-04-21
K964281 AESCULAP ANGLED NEUROENDOSCOPES Aesculap, Inc. GWG Class II 1997-04-21
K970203 EPIX VT Empi GZJ Class II 1997-04-14
K963631 SLEEP STUDY ANALYSIS (SSA) VERSION 96.10 Omega Results OLZ Class II 1997-04-02
K952683 APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE Wholesale Medical Imports, Inc. LIH Class II 1997-04-01
K964021 INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) Baxter Edwards HCG Class II 1997-03-27
K965174 TRUFILL PVA PARTICLES Cordis Neurovascular, Inc. HCG Class II 1997-03-21
K963507 EXTRA TENS (RI-2500) NEO TENS (RI-2000E) Comtek Intl., Corp. GZJ Class II 1997-03-19
K964224 STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE Pmt Corp. GYC Class II 1997-03-19
K964737 HYDROPREP GEL D.O. Weaver Co. GYB Class II 1997-03-19
K970696 S.P. 100 Lsi Intl., Inc. GZJ Class II 1997-03-18
K965182 RFG-3CF Radionics, Inc. GXD Class II 1997-03-12
K965078 2.1MM SEMI-RIGID NEUROVIEW SCISSORS/2.0OMM SEMI-RIGID NEUROVIEW GRASPING FORCEPS Neuro Navigational Corp. GWG Class II 1997-03-06
K965070 SPECTRUM 5000 Q, 5000Q,M,4000 Q, 4000 M. Mecta Corp. QGH Class II 1997-03-06
K965194 MEDICOM, TENS ELECTRODES Medicotest A/S GXY Class II 1997-03-06
K963662 GALILEO EVOKED POTENTIALRE Biosound, Inc. GWF Class II 1997-02-26
K961809 SHE-LI TENS STIMULATOR MODEL SL-101 RX Medi Consultants, Inc. GZJ Class II 1997-02-26
K960097 CHARTR EP Ics Medical Corp. GWJ Class II 1997-02-21
K963729 SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD) Skylark Device Co., Ltd. GZJ Class II 1997-02-13
K963125 M AND R REUSABLE ELECTRODES (MULTIPLE) M & R Mfg., Inc. GZJ Class II 1997-02-06
K965006 AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER) Stoelting Co. HCC Class II 1997-02-05
K960037 SUGITA AVM MICROCLIP Mizuho America, Inc. HCH Class II 1997-02-05
K964371 SHUNT TAP WITH ICP MONITORING ACCESS PORT Integra Neurocare, LLC JXG Class II 1997-01-31
K964386 RADIONICS CONTOUR FLEX PLUS VALVE Radionics, Inc. JXG Class II 1997-01-31
K964367 CES VASCULAR OCCLUSION SYSTEM Cordis Neurovascular, Inc. HCG Class II 1997-01-30
K964280 DG NERVUS Medelec , Ltd. GWQ Class II 1997-01-27
K964433 AQUABOND ELECTRODE Medibond , Ltd. GXY Class II 1997-01-27
K964537 BONESOURCE HYDROXYAPATITE CEMENT (HAC) Osteogenics, Inc. GXP Class II 1997-01-24
K964402 VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM V. Mueller Neuro/Spine GZT Class II 1997-01-23
K954717 SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY Sodem Diffusion SA HBB Class II 1997-01-22
K961636 MEDILOG VISION Oxford Instruments, Plc. OLZ Class II 1997-01-17
K961642 MEDILOG MR95 Oxford Instruments, Plc. GWQ Class II 1997-01-17
K961638 MEDILOG MPA-S Oxford Instruments Medical Systems OLV Class II 1997-01-17
K962455 FOUR-CHANNEL PREAMPLIFIER Cadwell Laboratories, Inc. GWF Class II 1997-01-13
K962458 CADWELL FOUR-/EIGHT-CHANNEL PREAMPLIFIER Cadwell Laboratories, Inc. GWF Class II 1997-01-13
K962457 TWO-CHANNEL PREAMPLIFIER Cadwell Laboratories, Inc. GWF Class II 1997-01-13
K963221 OPTICAL DIGITIZER OPTION FOR VIEW POINT Philips Medical Systems (Cleveland), Inc. HAW Class II 1997-01-10
K960915 CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX Clarus Medical Systems, Inc. GWG Class II 1996-12-24
K962928 COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/) Camino Neurocare, Inc. GWM Class II 1996-12-20
K955265 CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETER Cordis Corp. JXG Class II 1996-12-20
K963307 GDC PATIENT RETURN ELECTTRODE MODEL 45021 Target Therapeutics HCG Class II 1996-12-17
K962283 EEG ELECTRODES Teca, Inc. GXY Class II 1996-12-16
K961859 NOVUS STANDARD AND PEDIATRIC VALVES Integra Neurocare, LLC JXG Class II 1996-12-16
K963669 GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM Astro-Med, Inc. GWL Class II 1996-12-12
K962447 EQUINOX DIGITAL EEG SYSTEM Physiometrix, Inc. GWQ Class II 1996-12-12
K963802 SHUNT TAP Integra Neurocare, LLC JXG Class II 1996-12-12
K962157 MODEL 1310 NEUROLINK NEUROMONITORING SYSTEM Physiometrix, Inc. GWQ Class II 1996-11-25
K963577 RADIONICS SLUIJTER-MEHTA CANNULA Radionics, Inc. GXD Class II 1996-11-21
K962483 MIDAS REX III MOTOR Midas Rex Pneumatic Tools, Inc. HBB Class II 1996-11-19
K960630 ANSPAHC SPEED REDUCER The Anspach Effort, Inc. HBB Class II 1996-11-19
K953742 BIFURCATED Y-EXTENSION Medtronic Vascular GZB Class II 1996-11-19
K963236 M & R DISPOSABLE ELECTRODE (14200) M & R Mfg., Inc. GXY Class II 1996-11-15
K961834 PHILIPS EASYGUIDE NEURO Philips Medical Systems, Inc. HAW Class II 1996-11-08
K962764 NEUROMAG-122 Philips Medical Systems (Cleveland), Inc. OLY Class II 1996-10-31
K961645 MRS-2D Lexicor Medical Technology, Inc. HCC Class II 1996-10-31
K960159 CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS) Cordis Corp. JXG Class II 1996-10-25
K963173 STEALTHSTATION SYSTEM Surgical Navigation Technologies, Inc. HAW Class II 1996-10-25
K961844 OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES] Radionics Software Applications, Inc. HAW Class II 1996-10-23
K962990 RADIONICS SIPHON LIMITING DEVICE (SLD) Radionics, Inc. JXG Class II 1996-10-23
K955470 ACTION POTENTIAL SIMULATION THERAPY DEVICE Neurotech, Inc. GZJ Class II 1996-10-22
K955064 SPETZLER TI 100 ANEURYSM CLIP Elekta Instruments, Inc. HCH Class II 1996-10-17
K962761 REIGEL TUNNELING DEVICE Cook, Inc. GYK Class I 1996-10-11
K963644 A-1000 EEG MONITOR AND A-1050 EEG MONITOR Aspect Medical Systems, Inc. OLW Class II 1996-10-08
K954658 PERNECZKY CLIP APPLIER/REMOVER Von Zeppelin GmbH HCI Class II 1996-10-08
K962681 ECOGEL 300 TENS GEL Eco-Med Pharmaceuticals, Inc. GYB Class II 1996-10-04
K961821 ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR Aspect Medical Systems, Inc. GXY Class II 1996-10-04

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