meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
45
Latest Decision
2013-09-05

Clearances · page 23 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K123723 SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM Synthes GWO Class II 2013-09-05
K131184 INTEGRA LICOX PTO2 MONITOR Integra Lifesciences Corp. GWM Class II 2013-08-30
K130403 MAGSTIM DOUBLE 70-2 COIL The Magstim Company , Ltd. GWF Class II 2013-08-23
K123605 SMARTFLOW CATHETER Mri Interventions, Inc. HCA Class II 2013-08-16
K123633 TRS CRANIAL BONE VOID FILLER(TRS C-BVF) Tissue Regeneration Systems, Inc. GXR Class II 2013-08-16
K131425 NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER Medtronic Navigation, Inc. OLO Class II 2013-08-14
K130887 S4C NAVIGATION INSTRUMENTS Aesculap Implant System, Inc. OLO Class II 2013-08-13
K131415 LIVE VIEW PANEL (LVP) Neurotronics, Inc. OLV Class II 2013-08-09
K130608 QUADCUT Medtronic Navigation, Inc. HAW Class II 2013-08-07
K130541 SYMMETRY KERRISON DISPOSABLE TIP RONGEURS Symmetry Surgical HAE Class II 2013-08-05
K130748 SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0 Smith & Nephew, Inc. OLO Class II 2013-08-04
K131475 BARRICADE EMBOLIZATION COIL SYSTEM Blockade Medical HCG Class II 2013-07-25
K131159 SMARTRELIEF Chattem, Inc. NUH Class II 2013-07-25
K130220 MR CONDITIONAL PRESSON ELECTRODE Rhythmlink International, LLC GXZ Class II 2013-07-22
K130136 DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, Technomed Europe GXZ Class II 2013-07-19
K124055 T1040 AKA AURAWAVE Endurance Therapeutics NUH Class II 2013-07-19
K131130 NAVIGATION PIN Evergreen Orthopedic Research Lab OLO Class II 2013-07-19
K130987 VALUTRODE NEUROSTIMLATION ELECTRODES Axelgaard Mfg. Co., Ltd. GXY Class II 2013-07-17
K131434 VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM Visionsense, Ltd. GWG Class II 2013-07-16
DEN110019 NEBA SYSTEM Lexicor Medical Technology, LLC NCG Class II 2013-07-15
K130919 SENSUS Neurometrix, Inc. GZJ Class II 2013-07-02
K131568 SUDO PATH Ld Technology, LLC GZO Class II 2013-06-28
K131141 EARPROBE Path Medical GmbH GWJ Class II 2013-06-27
K130816 INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) Neuro Resource Group, Inc. GXY Class II 2013-06-21
K112598 AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) American Surgical Company, LLC HBA Class II 2013-06-20
K130545 MULTI LEAD TRIAL CABLE St Jude Medical GZB Class II 2013-06-18
K130309 RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM Biomet Microfixation GXR Class II 2013-06-17
K130380 ORTHOSENSOR KNEE BALANCER Orthosensor, Inc. ONN Class II 2013-06-13
K124023 STARBAND Orthomerica Products, Inc. OAN Class II 2013-06-10
K123843 NEUROEPG SYSTEM Strohl Medical Technologies GWF Class II 2013-06-05
K122791 LYOPLANT ONLAY Aesculap, Inc. GXQ Class II 2013-06-04
K123885 OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR Osteomed LP PBJ Class II 2013-06-03
K130287 MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE Rhythmlink International, LLC GXY Class II 2013-05-30
K123079 OLYMPIC BRAINZ MONITOR Excel-Tech Ltd. (Xltek) OMA Class II 2013-05-08
K130346 SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION Natus Neurology Incorporated GWF Class II 2013-05-02
K122196 CERVELLO BIO-POTENTIAL SIGNAL ACQUISTION SYSTEM PRODUCT FAMILY Blackrock Neuromed, LLC GWQ Class II 2013-05-02
K123636 H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE Bioness, Inc. GZI Class II 2013-05-01
K130233 NEUROSTAR TMS THERAPY SYSTEM Neuronetics OBP Class II 2013-04-30
K122225 STERILE RADIOLUCENT SKULL PINS Brainlab AG HBL Class II 2013-04-26
K130201 NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM Ototronix, LLC GWN Class II 2013-04-26
K123915 DE48-PLUS Grass Technologies, an Astro-Med, Inc. Product Gro GXY Class II 2013-04-24
K130389 MAYFIELD INFINITY XR2 SKULL CLAMP Integra LifeSciences Corporation HBL Class II 2013-04-23
K130007 SLEEP PROFILER Advanced Brain Monitoring, Inc. OLZ Class II 2013-04-17
K130114 PAINMASTER MCT PATCH Newmark, Inc. NUH Class II 2013-04-16
K122049 NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM Kinamed, Inc. GWO Class II 2013-04-05
K123796 NEURO OMEGA SYSTEM Alpha Omega Engineering , Ltd. GZL Class II 2013-04-05
K123701 HEARLAB ACA Frye Electronics, Inc. GWJ Class II 2013-04-05
K123972 WALKAIDE SYSTEM Innovative Neurotronics, Inc. GZI Class II 2013-04-01
K130497 D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION Linvatec Corporation D/B/A Conmed Linvatec HBC Class II 2013-03-29
K123338 BARRICADE EMBOLIZATION COIL SYSTEM Blockade Medical HCG Class II 2013-03-28
K123178 STRYKER VENOM ELECTRODES AND CANNULAE Stryker Instruments, Instruments Div. GXI Class II 2013-03-28
K122744 PROSPERA OTC TENS ELECTRONIC PULSE MASSAGER Prospera Corporation NUH Class II 2013-03-28
K123665 LIFELINES IEEG Kvikna Ehf OLT Class II 2013-03-25
K124004 NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS Medtronic Navigation, Inc. OLO Class II 2013-03-22
K122456 MRII CRAINIAL DRILL Mri Interventions, Inc. HBG Class II 2013-03-22
K123554 SHUNTCHECK Neurodx Development, LLC JXG Class II 2013-03-07
K123548 THE ARTAS SYSTEM Restoration Robotics, Inc. ONA Class II 2013-02-25
K123154 ARTAS SYSTEM FROM RESTORATION ROBOTICS Restoration Robotics, Inc. ONA Class II 2013-02-19
K123524 MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM Medtronic Neurosurgery JXG Class II 2013-02-13
K121818 OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE Oxford Performance Materials GXN Class II 2013-02-07
K122879 EEGER4 MODEL 4.3 Eeg Software, LLC HCC Class II 2013-02-06
K122550 ICS IMPULSE Gn Otometrics GWN Class II 2013-02-01
K130013 X4 SYSTEM Advanced Brain Monitoring, Inc. OMC Class II 2013-01-31
K113375 ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE Eswallow USA GXY Class II 2013-01-25
K123560 VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM Codman & Shurtleff, Inc. HCG Class II 2013-01-25
K123299 MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS St. Jude Medical Neuromodulation GZB Class II 2013-01-18
K123163 NEUROPACE BURR HOLE COVER MODEL 8110 NeuroPace, Inc. GXR Class II 2013-01-18
K121606 RESORB-X G KLS-Martin L.P. GWO Class II 2013-01-17
K121765 SCULPTOR ROBOTIC GUIDANCE ARM (RGA) Stanmore Implants Worldwide , Ltd. OLO Class II 2013-01-11
K123270 POWEREASE SYSTEM Medtronic Sofamor Danek USA, Inc. HBE Class II 2013-01-11
K123516 CRYO-TOUCH IV Myoscience, Inc. GXH Class II 2013-01-10
K122288 BRAINSWAY DEEP TMS SYSTEM Brainsway , Ltd. OBP Class II 2013-01-07
K122784 NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT Bioness, Inc. GZI Class II 2012-12-27
K122944 GEMORE TRUE SINE INTERFERENTIAL STIMULATOR Gemore Technology Co, Ltd. LIH Class II 2012-12-21
K122948 GEM-STIM COMBO STIMULATOR Gemore Technology Co, Ltd. GZJ Class II 2012-12-21
K123255 g.HIamp G.Tec Medical Engineering GmbH GWL Class II 2012-12-20
K121369 NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR Ibramed Equipamentos Medicos GZJ Class II 2012-12-19
K122376 PMT TRUSCAN SURFACE ELECTRODE Pmt Corp. GXY Class II 2012-12-19
K122211 SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS Synthes Spine HAW Class II 2012-12-17
K122742 NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM Nuvasive, Inc. OLO Class II 2012-12-07
K123377 TARGET DETACHABLE COIL Stryker Neurovascular HCG Class II 2012-11-30
K121936 NAVIOPFS Blue Belt Technologies, Inc. OLO Class II 2012-11-30
K122326 SMARTTOOLS KNEE SYSTEM Zimmer OLO Class II 2012-11-30
K121816 SENSUS ELECTRODE Neurometrix, Inc. GXY Class II 2012-11-26
K121662 VECTTOR VT-200 Alan Neuromedical Technologies, LLC LIH Class II 2012-11-21
K121757 HEALTHMATEFOREVER Healthmate International, LLC NUH Class II 2012-11-20
K122011 NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP Brainlab AG OLO Class II 2012-11-15
K120888 PSG-1100 SLEEP DIAGNOSTIC SYSTEM Nihon Kohden Corp. GWQ Class II 2012-11-09
K121483 REUSABLE CUTANEOUS ELECTRODE Ampcare, LLC GXY Class II 2012-10-15
K121624 BIOMET MICROFIXATION NEURO PLATING SYSTEM Biomet Microfixation GWO Class II 2012-10-12
K122096 KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM KARL STORZ Endoscopy-America, Inc. HAW Class II 2012-09-27
K122067 TYPE 1077 ACCUSCREEN Gn Otometrics GWJ Class II 2012-09-27
K121305 STERLING MEDICAL IMPULSE 3 STIMULATOR Armstrong Industries, Inc. Dha Mediquip Int. Dha S GZJ Class II 2012-09-25
K121755 CUSTOM CRANIOFACIAL IMPLANT (CCI) Kelyniam Global, Inc. GXN Class II 2012-09-25
K121773 NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE Biomerics GXI Class II 2012-09-21
K120867 VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS Medos International SARL OLO Class II 2012-09-20
K120450 SLEEP PROFILER Advanced Brain Monitoring, Inc. OLZ Class II 2012-09-19
K120397 MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM Nihon Kohden Corp. GWF Class II 2012-09-19
K121153 PEEK CUSTOMIZED CRAIAL IMPLANT KIT Stryker GWO Class II 2012-09-14
K121573 INTEGRA CAMINO ICP MONITOR Intrgra Lifesciences Corporation GWM Class II 2012-09-10

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