meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
39
Latest Decision
2004-09-30

Clearances · page 33 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K042364 PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES Lamont Medical, Inc. OLV Class II 2004-09-30
K042198 PS MEDICAL NEUROSURGICAL IMPLANTS Medtronic Neurosurgery JXG Class II 2004-09-24
K041330 IPLAN! FLOW Brainlab AG HAW Class II 2004-09-22
K041902 MANTRA ELECTRODE Mantra Intl. (Hk) , Ltd. GXY Class II 2004-09-22
K033543 NARCOTREND, MODEL COMPACT 4.0 Mt Monitortechnik GmbH & Co. KG OLW Class II 2004-09-17
K042072 CALLOS CMF BONE VOID FILLER Skeletal Kinetics, LLC GXP Class II 2004-09-16
K041021 RF INTRODUCTION CANNULA Epimed International, Inc. GXI Class II 2004-09-16
K042223 XLTEK CONNEX IP HEADBOX, MODEL 1054 Excel Tech. , Ltd. OMB Class II 2004-09-16
K033341 SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS Smith & Nephew, Inc. HAW Class II 2004-09-10
K041215 CRANIAL HELMET Otto Bock Healthcare LP MVA Class II 2004-09-09
K042309 BIOSOMNIA-V3 Oxford Biosignals Limited OMC Class II 2004-09-08
K041611 SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP Synthes (Usa) GXR Class II 2004-09-08
K041754 STRYKER MAESTRO SYSTEM Stryker Corp. HBB Class II 2004-09-07
K042301 PROTENS ELECTRODE Bio Protech, Inc. GXY Class II 2004-09-03
K041520 MANTRA TENS MODEL NT3 Mantra Intl. (Hk) , Ltd. GZJ Class II 2004-09-03
K042192 LOW FLOW OSV II HYDROCEPHALUS VALVE Integra Neurosciences Implants S.A. JXG Class II 2004-09-02
K042150 XLTEK TREX MODEL#10309 Excel Tech. , Ltd. GWQ Class II 2004-08-27
K033122 5000Z SYSTEM (OTC) Prizm Medical, Inc. NUH Class II 2004-08-25
K040368 VECTORVISION HIP 3.0 Brainlab AG HAW Class II 2004-08-23
K041359 BODY CLOCK STIMPLUS AND STIMPLUS PRO Body Clock Health Care, Ltd. GZJ Class II 2004-08-20
K041409 MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799 Inomed GmbH GZL Class II 2004-08-20
K041604 MACRO-MICRO DEPTH ELECTRODE Ad-Tech Medical Instrument Corp GZL Class II 2004-08-16
K041320 MODIFICATION TO NC-STAT Neurometrix, Inc. JXE Class II 2004-08-12
K041244 POLYGRAM NET BIOFEEDBACK APPLICATION Medtronic Vascular HCC Class II 2004-08-12
K041264 ELEKTA OY Elekta Neuromag OY OLX Class II 2004-08-10
K041953 VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART Conmedcorp GXY Class II 2004-08-09
K040358 XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 Excel Tech. , Ltd. GWF Class II 2004-08-06
K033399 GEODESIC EEG SYSTEM SERIES 100 Electrical Geodesics, Incorporated GWQ Class II 2004-08-04
K033730 PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES Pmt Corp. GZL Class II 2004-08-03
K041263 NEUROGUIDE ANALYSIS SYSTEM Applied Neuroscience, Inc. OLU Class II 2004-08-03
K032239 THERA-CREAM, MODEL TCT004 Prizm Medical, Inc. GYB Class II 2004-07-30
K031858 NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES Richard Wolf Medical Instruments Corp. GWG Class II 2004-07-29
K041000 DUREPAIR DURA REGENERATION MATRIX Medtronic Neurosurgery GXQ Class II 2004-07-27
K040979 ELEKTA MICRODRIVE, MODEL 916716 Elekta Instrument AB HAW Class II 2004-07-23
K040565 PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE Physician Industries, Inc. GXD Class II 2004-07-22
K041575 FENZIAN TREATMENT SYSTEM Eumedic Limited GZJ Class II 2004-07-16
K041620 NEURA WRAP NERVE PROTECTOR Integra Lifesciences Corp. JXI Class II 2004-07-16
K041649 SAPPHIRE NXT DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. HCG Class II 2004-07-16
K040554 ACTIGRAPH, MODEL AM7164-2.2 AND ACTIGRAPH WITH EXTENDED MEMORY, MODEL AM71256 Manufacturing Technology, Inc. GWQ Class II 2004-07-16
K031454 ACUMEN SURGICAL NAVIGATION SYSTEM Biomet, Inc. HAW Class II 2004-07-08
K041350 SYNTHES (USA) CHRONOS Synthes (Usa) GXP Class II 2004-07-08
K040007 INTERFERENTIAL STIMULATOR, MODEL BMLS02-6 Biomedical Life Systems, Inc. LIH Class II 2004-07-07
K041551 MODIFICATION TO: HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. HCG Class II 2004-07-07
K041670 BIS PEDIATRIC SENSOR Aspect Medical Systems, Inc. GXY Class II 2004-07-06
K040986 CADWELL LIMB MOVEMENT MODULE Cadwell Laboratories, Inc. LEL Class II 2004-07-01
K040932 EASYNET BODY POSITION MODULE Cadwell Laboratories, Inc. LEL Class II 2004-07-01
K041092 FAST START TENS, MODEL FS 3001 Vision Quest Industries, Inc. GZJ Class II 2004-07-01
K041518 CODMAN DURAFORM DURAL GRAFT IMPLANT Codman & Shurtleff, Inc. GXQ Class II 2004-06-22
K041369 NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 Orthosoft, Inc. HAW Class II 2004-06-22
K033868 SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS Synthes (Usa) GXN Class II 2004-06-21
K040864 CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM Aesculap GXN Class II 2004-06-17
K040943 MEDTRONIC PS MEDICAL STRATA VALVE Medtronic Neurosurgery JXG Class II 2004-06-15
K041296 MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI Codman & Shurtleff, Inc. JXG Class II 2004-06-10
K040834 NAVIGUS PASSIVE PROBE (BL), MODEL NP-2000 Image-Guided Neurologics, Inc. HAW Class II 2004-06-03
K041198 NIC36 AMPLIFIER Eb Neuro S.P.A. GWL Class II 2004-06-01
K033704 MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS Vygon Us, LLC JXG Class II 2004-05-27
K040512 LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401 Well-Life Healthcare, Inc. GZJ Class II 2004-05-27
K040639 ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE Isurgical GXZ Class II 2004-05-21
K041164 L-TENS Fuji Dynamics Limited GZJ Class II 2004-05-20
K040152 BONE CEMENT FOR CRANIOPLASTY Cardinalhealth GXP Class II 2004-05-19
K024245 ENVOY PATIENT MONITOR Mennen Medical , Ltd. OMC Class II 2004-05-10
K040824 INTERFERENTIAL STIMULATOR, MODEL BMLS03-6 Biomedical Life Systems, Inc. LIH Class II 2004-04-29
K040193 MODEL GST-1 Medical Equipment Device Specialists GZJ Class II 2004-04-27
K040235 LICOX PMO BRAIN MONITORING SYSTEM Integra LifeSciences Corporation GWM Class II 2004-04-20
K023916 BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294 Bio-Medical Research, Ltd. GZJ Class II 2004-04-15
K040186 ANSPACH MRI SAFE SURGICAL DRILL SYSTEM The Anspach Effort, Inc. HBB Class II 2004-04-15
K040253 EASY MED TN-28 C Easy Med Instrument Co., Ltd. GZJ Class II 2004-04-08
K033017 PHOENIX INFUSION CATHETER Phoenix Biomedical JXG Class II 2004-04-07
K032406 STRYKER RF ELECTRODES AND CANNULAE Stryker Instruments GXI Class II 2004-04-01
K032601 STRYKER INTERVENTIONAL PAIN RF GENERATOR Valley Forge Scientific Corp. GXD Class II 2004-04-01
K040080 AESCULAP ABSORBABLE CRANIOFIX Aesculap, Inc. GXR Class II 2004-03-31
K023525 RETISCAN, RETIPORT Roland Consult GWE Class II 2004-03-26
K040568 POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS Medtronic Vascular GZB Class II 2004-03-25
K040609 RAPID PROGRAMMER Advanced Neuromodulation Systems GZB Class II 2004-03-25
K040694 MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D) Micro Therapeutics, Inc. HCG Class II 2004-03-25
K040051 MEGVISION, MODEL EQ1000C SERIES Eagle Technology, Inc. OLX Class II 2004-03-24
K033173 MICRO TARGETING ELECTRODE FHC, Inc. GZL Class II 2004-03-24
K040595 ALICE 5 Respironics, Inc. OLZ Class II 2004-03-18
K034012 SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE Smith & Nephew, Inc. GXI Class II 2004-03-16
K040076 ANSPACH ADVANCED MICRO SAW ATTACHMENTS The Anspach Effort, Inc. HBE Class II 2004-03-15
K040360 EMU128S, MODEL EX-NW-128S Excel Tech. , Ltd. GWQ Class II 2004-03-12
K033668 NAVIPRO KNEE SOFTWARE MODULE Kinamed, Inc. HAW Class II 2004-03-11
K032278 AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE Ambu, Inc. GXY Class II 2004-03-05
K031930 HIGH SPEED EMG MODULE Medical Measurement Systems B.V. GWF Class II 2004-03-03
K033619 NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000 Image-Guided Neurologics, Inc. HAW Class II 2004-03-02
K031097 POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB Sophysa SA JXG Class II 2004-02-26
K040201 MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM Integra Neurosciences Implants S.A. JXG Class II 2004-02-26
K040183 BISX Aspect Medical Systems, Inc. OLW Class II 2004-02-25
K033395 CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1 Codman & Shurtleff, Inc. GXO Class II 2004-02-25
K031051 SMARTEP-ASSR, MODEL M811007 Intelligent Hearing Systems GWJ Class II 2004-02-20
K040113 SANDMAN SD20 AMPLIFIER Eb Neuro S.P.A. GWL Class II 2004-02-18
K033223 ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS Zimmer, Inc. HAW Class II 2004-02-18
K033978 ADAM Astro-Med, Inc. GWQ Class II 2004-02-18
K023651 VECTORVISION CRANIAL/ENT Brainlab AG HAW Class II 2004-02-17
K032619 MICROSTAT PVA FOAM EMBOLIZATION PARTICLES Surgica Corp. HCG Class II 2004-02-13
K033340 LEKSELL SURGIPLAN WITH IMAGEMERGE Elekta Instrument AB HAW Class II 2004-02-12
K033011 ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS Zimmer, Inc. HAW Class II 2004-02-12
K033999 SEDLINE WITH FRONTAL PSI Physiometrix, Inc. OLW Class II 2004-02-06
K033761 GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES Biocompatibles UK Limited HCG Class II 2004-02-04
K033813 MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE Micrus Corp. HCG Class II 2004-02-04

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