meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
45
Latest Decision
2007-12-20

Clearances · page 29 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K071482 STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 Synergetics, Inc. GXD Class II 2007-12-20
K072707 PATIENT CONTOURED MESH-PEEK (PCM-P) KLS-Martin L.P. GXN Class II 2007-12-19
K072271 STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE Stryker Corp. HAW Class II 2007-12-18
K072758 SYNTHES (USA) 2.0MM TITANIUM T-PLATE Synthes (Usa) GWO Class II 2007-12-18
K072267 TOTAL HIP SURGETICS NAVIGATION SYSTEM Praxim S.A HAW Class II 2007-12-10
K072601 OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT Osteosymbionics, LLC GXP Class II 2007-12-10
K072929 LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030 Integra LifeSciences Corporation JXG Class II 2007-12-07
K071878 DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB Med-Lectric Corporation GZJ Class II 2007-12-07
K071697 NEURONAV SYSTEM AND NEURONAV DRIVE Alpha Omega , Ltd. GZL Class II 2007-12-03
K060846 THERAPEUTIC MASSAGE COMPANION Endurance Therapeutics NUH Class II 2007-12-03
K071624 EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR Everlife Medical Equipment Co., Ltd. GZJ Class II 2007-11-27
K072260 NUFACE, MODEL NU-4003 Carol Cole Company NFO Class II 2007-11-27
K072398 RT300-S AND RT300-SP FES CYCLE ERGOMETER Restorative Therapies, Inc. GZI Class II 2007-11-21
K072286 BIS EEG VISTA MONITOR SYSTEM AND BISX Aspect Medical Systems, Inc. OLW Class II 2007-11-20
K072343 NEUROVISION JJB SYSTEM Nuvasive, Inc. GWF Class II 2007-10-29
K071899 BIS MODULE FOR ENVOY PATIENT MONITOR Mennen Medical , Ltd. OLW Class II 2007-10-22
K071931 CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 Codman & Shurtleff, Inc. HBF Class II 2007-10-22
K072016 CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE Technomed Europe GXY Class II 2007-10-19
K072716 VECTOR VISION HIP Brainlab AG HAW Class II 2007-10-12
K072462 WIDE SPACED QUATTRODE LEADS Advanced Neuromodulation Systems GZB Class II 2007-10-11
K072573 VECTORVISION HIP AND HIP SR Brainlab AG HAW Class II 2007-10-11
K072173 MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC Micrus Endovascular Corporation HCG Class II 2007-10-05
K071962 VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER) Cordis Neurovascular, Inc. HCG Class II 2007-09-26
K070556 BRAINSUITE NET Brainlab AG HAW Class II 2007-09-25
K071929 NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL Orthosoft, Inc. HAW Class II 2007-09-19
K062003 NEURO WAVE 6 Lhasa Oms, Inc. GZJ Class II 2007-09-19
K072315 MIDAS REX CURVED BUR Medtronic Powered Surgical Solutions HBE Class II 2007-09-18
K070670 EYETRACKER/IDEAS S.A. Instrumentation Difra GWN Class II 2007-09-18
K071449 BRM3 BRAIN MONITOR Brainz Instruments , Ltd. OMA Class II 2007-09-14
K071486 RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053 Restorative Therapies, Inc. GZI Class II 2007-09-10
K070694 CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) Mike Miner MVA Class II 2007-09-10
K072208 MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS Integra LifeSciences Corporation HBL Class II 2007-09-07
K071118 GOLD CUP ELECTRODE, SILVER CUP ELECTRODE AND ELECTRODE WITH AG-AG/CL COATING AND CONDUCTIVE PLASTIC ELECTRODE Ives Eeg Solutions, Inc. GXY Class II 2007-09-07
K071951 COMFY SERIES: EV-804, EV-805 & EV-806 Everyway Medical Instruments Co.,Ltd GZJ Class II 2007-09-05
K071661 ALPHAONE BIOFEEDBACK SYSTEM Telediagnostic Systems, Inc. HCC Class II 2007-09-05
K061828 LORENZ BIOTECH APTIVA, VERSION 2.13 Lorenz Biotech S.P.A. GZJ Class II 2007-08-24
K072207 DURAGEN XS DURAL REGENERATION MATRIX Integra Lifesciences Corp. GXQ Class II 2007-08-23
K063607 SPINEASSIST SYSTEM Mazor Surgical Technologies , Ltd. HAW Class II 2007-08-23
K063729 DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 Technomed Europe GXZ Class II 2007-08-21
K063836 RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715 Medtronic Neurosurgery JXG Class II 2007-08-16
K071138 CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM Prosurg, Inc. GXR Class II 2007-08-15
K071505 MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM Integra LifeSciences Corporation GWM Class II 2007-08-06
K070272 NEUROPORT ELECTRODE Cyberkinetics Neurotechnology Systems, Inc. GZL Class II 2007-08-03
K071771 INSTRUMED RETRACTORS Instrumed International, Inc. GZT Class II 2007-08-02
K070731 PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEM Plus Orthopedics AG HAW Class II 2007-07-31
K070358 MAXINSIGHT Eemagine Medical Imaging Solutions GmbH OLX Class II 2007-07-30
K071791 MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 Codman & Shurtleff, Inc. GXP Class II 2007-07-30
K071821 COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65 Tonica Elektronik A/S GWF Class II 2007-07-27
K071776 ANEUROPLASTIC, MODEL 43-1290 Codman & Shurtleff, Inc. JXH Class II 2007-07-26
K071364 MICROTARGETING GUIDELINE 4000 FHC, Inc. GZL Class II 2007-07-25
K071714 NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 Orthosoft, Inc. HAW Class II 2007-07-20
K071300 MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE Smith & Nephew, Inc. GXI Class II 2007-07-20
K071745 BAYLIS PAIN MANAGEMENT SINGLE-USE PROBE Baylis Medical Co., Inc. GXI Class II 2007-07-19
K070608 SMARTEP, MODEL M010000 Intelligent Hearing Systems GWJ Class II 2007-07-18
K070299 EZFIT DIGITAL HEATING TENS (MODEL NO.: HR-661/UC-101) Ezfit Technology, Inc. GZJ Class II 2007-07-16
K071640 VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM Cook, Inc. NHC Class II 2007-07-12
K071634 MODIFICATION TO:CONTOUR SE MICROSPHERES Boston Scientific Corp HCG Class II 2007-07-12
K062616 WELLNESSPRO 2010 Intelsource Group, Inc. GZJ Class II 2007-07-06
K062584 PRESSIO ICP MONITORING SYSTEM Sophysa SA GWM Class II 2007-07-05
K071113 RT300-S, MODEL FA100052, RT300-SP (PEDIATRIC VERSION), MODEL FA100053 Restorative Therapies, Inc. GZI Class II 2007-07-05
K071334 DEPUY CAS HEMI ASR HIP INSTRUMENTS DePuy Orthopaedics, Inc. HAW Class II 2007-07-02
K063133 CRANIAL SOLUTION ORTHOSIS Cranial Solutions MVA Class II 2007-07-02
K070696 INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) Interacoustics A/S GWJ Class II 2007-06-29
K070890 EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 Everlife Medical Equipment Co., Ltd. LIH Class II 2007-06-29
K063753 GFX NERVE ABLATION SYSTEM Aci, Inc. GXD Class II 2007-06-20
K062613 BIS EEG MONITOR VIEW Aspect Medical Systems, Inc. OLW Class II 2007-06-18
K070901 MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. GXN Class II 2007-06-15
K070656 HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. HCG Class II 2007-06-15
K070336 STOCKERT NEURO N50, MODEL12267 Stockert GmbH GXD Class II 2007-06-14
K071458 MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS Integra LifeSciences Corporation HBL Class II 2007-06-13
K071109 SACS EEG WORKSTATION A7 Sacs Medical AB GWQ Class II 2007-06-07
K071246 MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR Micrus Endovascular Corporation HCG Class II 2007-06-01
K071185 MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE Ambu A/S GXZ Class II 2007-05-30
K071338 FLEX ARM RETRACTOR SYSTEM Koros USA, Inc. GZT Class II 2007-05-29
K071173 RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D Ossur Americans (Formerly the Jerome Group) HAX Class II 2007-05-25
K063743 RHYTHM TOUCH Q 2-WAY Shockim Enterprises, Ltd. NUH Class II 2007-05-24
K070807 CUTANEOUS ELECTROTHERAPY AND RECORDING ELECTRODES; TENS ELECTRODES Pepin Mfg., Inc. GXY Class II 2007-05-23
K071135 DEPUY CI HIP INSTRUMENTATION DePuy Orthopaedics, Inc. HAW Class II 2007-05-23
K063489 STRYKER INTRADISCAL RF GENERATOR Synergetics, Inc. GXD Class II 2007-05-23
K063494 DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS Pro-Med Instruments GmbH HBL Class II 2007-05-21
K062943 POLYSMITH SLEEP SYSTEM, MODEL NTI5498 Neurotronics, Inc. OLZ Class II 2007-05-09
K070612 TOP-RANK ADHESIVE ELECTRODE Top-Rank Health Care Equipment Co., Ltd. GXY Class II 2007-05-07
K062641 BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1 Avazzia, Inc. GZJ Class II 2007-04-30
K070876 STRYKER TWIST DRILLS Stryker Craniomaxillofacial HBE Class II 2007-04-27
K070474 NEWLIFE SCIENCES LLC, MODEL TMR Newlife Sciences, LLC GZJ Class II 2007-04-25
K060747 FX DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. HCG Class II 2007-04-24
K070106 VV FLUORO 3D Brainlab AG HAW Class II 2007-04-23
K060915 KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS Kirwan Surgical Products, Inc. HCH Class II 2007-04-17
K063231 MICROBLADE SHAVER AND ACCESSORIES Baxano, Inc. HAE Class II 2007-04-16
K062325 RS-4I MUSCLE STIMULATOR FAMILY Rs Medical NYN Class II 2007-04-13
K063098 STATIC CRANIOPLASTY ORTHOSIS Boston Brace Intl., Inc. OAN Class II 2007-04-11
K070847 TRIAL CABLE, 3009 Advanced Neuromodulation Systems GZB Class II 2007-04-11
K070707 MICRUS MICROCOIL SYSTEM Micrus Endovascular Corporation HCG Class II 2007-04-06
K063872 KINESIA Cleveland Medical Devices, Inc. GYD Class II 2007-04-06
K061479 ARGOS 3D Line Medical Systems S.R.L. HAW Class II 2007-04-05
K062284 CES ULTRA Neuro-Fitness, LLC QJQ Class II 2007-04-05
K070108 ELIBRA DYNAMIC KNEE BALANCER Synvasive Technology, Inc. ONN Class II 2007-04-04
K070729 BALANCEBACK MOBILE INTUITIVE VNG SYSTEM Fall Prevention Technologies, LLC GWN Class II 2007-03-30
K063599 PORTI 7 PHYSIOLOGICAL AMPLIFIER Tms International BV GWL Class II 2007-03-22
K062547 QUADRA BLOC TENS, MODEL 101 Gradient Technologies, LLC GZJ Class II 2007-03-21

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