meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
52
Latest Decision
2015-05-22

Clearances · page 21 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K150801 Stryker Maestro Air Motors Stryker Corporation HBB Class II 2015-05-22
K142666 Scrambler Therapy MC-5 A Device Delta International Services & Logistics S.R.L GZJ Class II 2015-05-22
K142567 RETeval Visual Electrodiagnostic Device Lkc Technologies, Inc. GWE Class II 2015-05-19
K143643 Brainscope Ahead 200 Brainscope Company, Inc. PIW Class II 2015-05-15
K141883 CLINISCANSM EEG Picofemto, LLC OMB Class II 2015-05-15
K150681 GEMORE OTC TENS Gemore Technology Co, Ltd. NUH Class II 2015-05-12
K143531 Rapid Therapy System Magstim Company Limited OBP Class II 2015-05-08
K143399 Stryker Footed Attachments and Cutting Accessories Stryker Corp. HBE Class II 2015-05-08
K143540 Stryker MIS Attachments and Cutting Accessories Stryker Corporation HBE Class II 2015-05-01
K143024 CAS-One Liver Cascination AG OEW Class II 2015-04-28
K142624 Neuromaster G1 MEE200 Nihon Kohden Corporation GWF Class II 2015-04-24
K143320 Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments Stryker Corp. HBE Class II 2015-04-23
K142141 STARBAND, STARLIGHT Orthomerica Products, Inc. OAN Class II 2015-04-23
K143440 Natus Quantum Natus Medical Incorporated GWQ Class II 2015-04-20
K150473 FlexPointer 1.5 mm Fiagon GmbH PGW Class II 2015-04-16
K150428 Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs Integra Lifesciences Corp. HAE Class II 2015-04-16
K143506 BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES) Covidien GXY Class II 2015-04-16
K150660 Alcyone MEMS Cannula (AMC) System Alcyone Lifesciences, Inc. HCD Class I 2015-04-16
K143241 MDT Navigable Brain Biopsy Cannula Izi Medical Products, LLC HAW Class II 2015-04-13
K141687 AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM Aesculap, Inc. JXG Class II 2015-04-02
K141227 POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX Sophysa SA JXG Class II 2015-04-02
K142024 BRIGHTMATTER NAVIGATION SYSTEM Synaptive Medical, Inc. HAW Class II 2015-04-02
K141812 MYGAIT STIMULATION SYSTEM Otto Bock Healthcare Products GmbH GZI Class II 2015-04-02
K141385 DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) Depuy Synthes Companies of Johnson & Johnson HBW Class II 2015-03-27
K141833 STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION Medtronic Navigation, Inc. HAW Class II 2015-03-25
K142236 BioniCare Hand System Vision Quest Industries, Inc. NYN Class II 2015-03-23
K143668 Navio Blue Belt Technologies, Inc. OLO Class II 2015-03-20
K142344 DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System Izi Medical Products, LLC HAW Class II 2015-03-20
K143218 Penumbra Smart Coil Penumbra, Inc. HCG Class II 2015-03-18
K142988 Sleepware G3 Respironics, Inc. OLZ Class II 2015-03-16
K141455 EASYDRILL AUTOSTOP CRANIAL PERFORATOR Micromar Ind. Com. , Ltd. HBF Class II 2015-03-16
K130238 NIHON KOHDEN AE-918P NEURO UNIT Nihon Kohden Corp. OMA Class II 2015-03-04
K133789 DOLPHIN NEUROSTIM OTC Acumed Medical , Ltd. NUH Class II 2015-03-04
K141559 V-GUIDE FOR VENTRICULOSTOMIES Arc Surgical, LLC HAW Class II 2015-02-27
K141123 ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM Alliance Partners, LLC GWO Class II 2015-02-27
K141694 AESCULAP ORTHOPILOT NEXT GENERATION Aesculap Implant Systems, LLC OLO Class II 2015-02-24
K142432 StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit Bioness, Inc. GZF Class II 2015-02-20
K143111 Codman Certas Plus Programmable Valve; Codman Certas Toll Kit Medos International SARL JXG Class II 2015-02-19
K142774 Polysmith Sleep System Neurotronics, Inc. OLV Class II 2015-02-18
K142064 GALILEO NT Eb Neuro S.P.A. OLT Class II 2015-02-13
K141316 COGNISION EEG/EP SYSTEM Neuronetrix Solutions OLT Class II 2015-02-13
K143628 Navigated Vertex Select Instruments Medtronic Sofamor Danek USA, Inc. OLO Class II 2015-02-12
K141911 OPTIMUS NEURO SYSTEM Osteonic Co., Ltd. GWO Class II 2015-02-10
K131335 BWMINI EEG, BWMINIHST, BWMINI PSG Neurovirtual USA, Inc. GWQ Class II 2015-02-03
K142866 Myoscience iovera system Myoscience, Inc. GXH Class II 2015-01-21
K142825 Zmachine Consolidated Research of Richmond, Inc. OLZ Class II 2015-01-20
K141608 COLLAGEN DURA MEMBRANE Collagen Matrix, Inc. GXQ Class II 2015-01-16
K143068 Medical Monofilament Sensory Screening Toool Medical Monofilament Manufacturing GXB Class I 2015-01-14
K140722 INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS Integra LifeSciences Corporation JXG Class II 2015-01-06
K141586 OWL CANNULAE Diros Technology, Inc. GXI Class II 2014-12-30
K142429 CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable Codman & Shurtleff, Inc. HCG Class II 2014-12-24
K130447 SPEEDY FLAP SYSTEM Jeil Medical Corporation GXN Class II 2014-12-22
K142686 StimPad OTC Aemed, Inc. NUH Class II 2014-12-18
K140680 LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM Alpine Biomed Aps GZL Class II 2014-12-12
K140705 NAVIGABLE BRAIN BIOPSY CANNULA SET Izi Medical Products HAW Class II 2014-12-05
K141978 MAXPOWER RELIEF Omron Healthcare, Inc. NUH Class II 2014-12-03
K133502 5000Z FIREFLY SYSTEM Prizm Medical, Inc. NUH Class II 2014-12-03
K142203 Atricure Cryo Module System; cryoICE cryoablation probe AtriCure, Inc. GXH Class II 2014-11-25
K142238 MAYFIELD Skull Clamp Integra LifeSciences Corporation HBL Class II 2014-11-24
K141872 SUDOSCAN Impeto Medical, Inc. GZO Class II 2014-11-21
K142099 CUTANEOUS ELECTRODES Bio Protech, Inc. GXY Class II 2014-11-17
DEN140025 BrainScope Ahead 100 Brainscope Company, Inc. PIW Class II 2014-11-17
K140586 ASCEND ELECTRODE Neurometrix, Inc. GXY Class II 2014-11-17
K142315 MINOP Disposable Introducer 26F Aesculap, Inc. GWG Class II 2014-11-14
K141299 OTC COMBO TENS/EMS SYSTEM Well-Life Healthcare Limited NUH Class II 2014-11-14
K141076 GARMENT ELECTRODES Shenzhen Dongdixin Technology Co., Ltd. GXY Class II 2014-11-14
K141342 WEARABLE THERAPY GARMENTS Axiobionics, LLC GXY Class II 2014-11-14
K141989 MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM Mako Surgical Corporation OLO Class II 2014-11-13
K142513 Barricade Embolization Coil System Blockade Medical HCG Class II 2014-11-13
K133929 HEALTH EXPERT ELCTRONIC STIMULATOR Shenzhen Osto Technology Company Limited NUH Class II 2014-11-12
K141644 INNOVASIS CRANIAL SYSTEM Innovasis, Inc. GWO Class II 2014-11-07
DEN130019 ZANZA-CLICK Tecnimed S.R.L. OSG Class II 2014-11-07
DEN100024 ZAP-IT! Ecobrands , Ltd. OSG Class II 2014-11-07
K142470 E-Shield Multi-paried Subdermal Needle Electrodes Neuroinvent, Inc. GXZ Class II 2014-11-05
K141941 SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D Stryker Corporate OLO Class II 2014-10-31
K140927 UNIVERSAL NAVIGATION INSTRUMENTS Medos International SARL OLO Class II 2014-10-24
K141869 QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT Hemedex Incorporated GWM Class II 2014-10-10
K141399 FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM Stimwave Technologies Incorporated GZB Class II 2014-10-10
K141456 THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL Fiagon GmbH PGW Class II 2014-10-08
K141842 STARBAND, STARLIGHT Orthomerica Products, Inc. MVA Class II 2014-10-06
K140309 CRANIOPLUG Ossdsign AB GXR Class II 2014-10-03
K140369 MEDLINE NEURO SPONGE Medline Industries, Inc. HBA Class II 2014-09-26
K141260 ELECTRONIC PULSE STIMULATOR Shenzhen Jingkehui Electronic Co.., Ltd. NUH Class II 2014-09-17
K141601 IASSIST KNEE SYSTEM Zimmer Cas OLO Class II 2014-09-11
K140167 RENAISSANCE X SYSTEM Mazor Robotics , Ltd. OLO Class II 2014-09-10
K141551 PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES) Stryker Corporate PGW Class II 2014-09-08
K141950 HFD100 ROCKER ARM ACCESSORY Imris, Inc. HBL Class II 2014-09-04
K140168 EASYSTIM TN28_OTC Easymed Instruments Co., Ltd. NUH Class II 2014-08-28
K133979 TENS Sunmas (H.K.) Trading Limited NUH Class II 2014-08-26
K141446 ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER, Natus Medical Incorporated GWJ Class II 2014-08-22
K140689 IKNEE DISTAL FEMORAL CUTTING GUIDE Evergreen Orthopedic Research Lab OLO Class II 2014-08-22
DEN120017 Medtronic DUET External Drainage and Monitoring System Medtronic Neurosurgery PCB Class II 2014-08-22
K140086 PERSONAL KINETIGRAPH (PKG) SYSTEM Gkc Manufacturing Pty, Ltd. GYD Class II 2014-08-22
K140585 CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM Curexo Technology Corporation OJP Class II 2014-08-18
K140886 WALKAIDE SYSTEM Innovative Neurotronics, Inc. GZI Class II 2014-08-08
K131290 IQ TECHNOLOGIES Iq Technologies, Inc. NUH Class II 2014-08-06
K131720 HIVOX SELF ADHESIVE ELECTRODE GEL PADS Hivox Biotek, Inc. GXY Class II 2014-07-25
K121119 BNA ANALYSIS SYSTEM Eiminda , Ltd. OLU Class II 2014-07-25
K133444 STEALTHSTATION S7 / I7 / FUSION NAVIGATION SYSTEMS, AXIEM NAVIGATION SYSTEM Medtronic Navigation, Inc. HAW Class II 2014-07-25
K141208 DYNAMIC NEUROSCREENING DEVICE Prosenex LQW Class I 2014-07-23

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