meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
43
Latest Decision
2014-07-23

Clearances · page 22 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K133759 INTELLIJOINT HIP Intellijoint Surgical, Inc. OLO Class II 2014-07-23
K140552 CADWELL SPIKE AND SEIZURE DETECTOR Cadwell OMB Class II 2014-07-23
K133419 BABYMEG BIOMAGNETOMETER SYSTEM Tristan Technologies, Inc. OLY Class II 2014-07-21
K140200 E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES Neuroinvent, Inc. GXZ Class II 2014-07-18
K141368 NEUROPACE BURR HOLE COVER NeuroPace, Inc. GXR Class II 2014-07-11
K131513 SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY Ritm Okb Zao GZJ Class II 2014-07-11
K131923 NEURODYN PORTABLE TENS NFES, NEURODYN PORTABLE TENS Techlink International GZI Class II 2014-07-03
K140333 ASCEND Neurometrix, Inc. NUH Class II 2014-07-03
K141134 POD SYSTEM Penumbra, Inc. HCG Class II 2014-07-03
K141452 LEFORTE NEURO SYSTEM BONE PLATE AND SCREW Jeil Medical Corporation GWO Class II 2014-07-02
K140596 NAVIO Blue Belt Technologies, Inc. OLO Class II 2014-07-02
K140650 HIVOX ELECTRIC STIMULATOR OTC TENS Hivox Biotek, Inc. NUH Class II 2014-06-27
K130755 HICUT HIGHSPEED INSTRUMENT Adeor Medical AG HBE Class II 2014-06-27
K140462 MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM) Synthes (USA) Products, LLC GWO Class II 2014-06-13
K140331 ORTHALIGN PLUS SYSTEM Orthalign, Inc. OLO Class II 2014-06-10
K140353 STARBAND AND STARLIGHT Orthomerica Products, Inc. MVA Class II 2014-06-06
K140868 STRYKER KWIC NEEDLE Orthovita, Inc. HAW Class II 2014-06-05
K123795 AXON-BUS PROSTHETIC SYSTEM Otto Bock Austria GXY Class II 2014-06-03
K133779 CP RELIEF WAND Mid-America Medical Innovations, LLC GZJ Class II 2014-05-30
K132416 REHASTIM 2, ERIGOPRO (FES) Hasomed GmbH GZI Class II 2014-05-28
K140038 DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM Curexo Technology Corporation OJP Class II 2014-05-27
K123099 Best-AV2 Pro-Sport(tm) Avazzia, Inc. GZJ Class II 2014-05-23
K140454 NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS Medtronic Sofamor Danek USA, Inc. OLO Class II 2014-05-22
K140340 SKINTACT Leonhard Lang GmbH GXY Class II 2014-05-21
K140094 SPRINGTMS TOTAL MIGRAINE SYSTEM Eneura Therapeutics, LLC OKP Class II 2014-05-21
K133082 OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE Osteosymbionics, LLC GXN Class II 2014-05-20
K133793 PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE Persyst Development Corporation OMB Class II 2014-05-19
K140272 SWIFT-LOCK ANCHOR St Jude Medical GZB Class II 2014-05-02
K130065 BEAUTIFUL IMAGE FACIAL SCULPTING DEVICE Biosonic Technologies, LLC NFO Class II 2014-04-30
K133573 FIAGON NAVIGATION SYSTEM Fiagon GmbH PGW Class II 2014-04-30
K132755 NEUROMATE FRAMELESS GEN II Renishaw Mayfield Sarl HAW Class II 2014-04-29
K130557 NEURAGEN 3D Integra LifeSciences Corporation JXI Class II 2014-04-24
K132993 COUNTER OTC TENS DEVICE Counter Scientific Development (Gz), Ltd. NUH Class II 2014-04-24
K131956 QUICK RELAX PRO Healthcare Innovations, LLC NUH Class II 2014-04-24
K132563 PINOOK STIMULATOR Pinook USA NUH Class II 2014-04-24
K133397 P-POD P-Pod MVA Class II 2014-04-18
K133823 NUFACE MINI DEVICE Carol Cole Company NFO Class II 2014-04-17
K131944 IEEG Jordan Neuroscience, Inc. OMC Class II 2014-04-10
K131541 FLEXIBLE COOAGEN NERVE CUFF Collagen Matrix, Inc. JXI Class II 2014-04-03
K132850 BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM Rti Surgical, Inc. GXQ Class II 2014-03-31
K133408 NEUROSTAR TMS THERAPY SYSTEM Neuronetics OBP Class II 2014-03-28
K133453 IOVERA Myoscience, Inc. GXH Class II 2014-03-24
K132104 ELIBRA SOFT-TISSUE FORCE SENSOR Kamm & Associates ONN Class II 2014-03-21
K132436 VARIOGUIDE DRILL KIT Mri Interventions, Inc. HBE Class II 2014-03-20
K133665 MALLEABLE SUCTION INSTRUMENTS Medtronic Navigation, Inc. PGW Class II 2014-03-13
K131675 BODIHEALTH SYSTEM Eprt Technologies, Inc. GZJ Class II 2014-03-12
DEN120019 CEFALY Stx-Med Sprl PCC Class II 2014-03-11
K132611 MICROTABLE SYSTEM Fred Haer Company, Inc. HAW Class II 2014-03-06
K133754 INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER Integra LifeSciences Corporation GWM Class II 2014-03-06
K132957 MADSEN ACCUSCREEN TYPE 1077 Gn Otometrics GWJ Class II 2014-02-27
K133517 NEMUS 2 SYSTEM Eb Neuro S.P.A. GWL Class II 2014-02-26
K131266 TREZ_HD Excel-Tech Ltd. (Xltek) GWQ Class II 2014-02-14
K132422 PALS PLATINUM NEUROSTIMULATION ELECTRODES Axelgaard Mfg. Co., Ltd. GXY Class II 2014-02-13
K140104 BARRICADE EMBOLIZATION COIL SYSTEM Blockade Medical HCG Class II 2014-02-13
K131882 GEODESICEEG SYSTEM 400 SERIES (GES 400) Electrical Geodesics, Inc. OLT Class II 2014-02-12
K133355 CADWELL FLEX EEG/PSG Cadwell Industries, Inc. GWQ Class II 2014-01-29
K133723 OTC PATCH Well-Life Healthcare Limited NUH Class II 2014-01-28
K132616 EPAD Safeop Surgical, Inc. GWF Class II 2014-01-24
K131910 MPP Marc Pro NUH Class II 2014-01-24
K131500 YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS Aesculap, Inc. HCH Class II 2014-01-24
K132057 DYNATRON PELTIER THERMOSTIM PROBE Dynatronics Corp. GXY Class II 2014-01-24
K132764 MOTION WATCH AND PRO-DIARY Camntech, Ltd. LEL Class II 2014-01-21
K132931 APOLLO SYSTEM Penumbra, Inc. GWG Class II 2014-01-17
K133250 STARLIGHT Orthomerica Products, Inc. OAN Class II 2014-01-16
K133310 AXIUM DETACHABLE COIL SYSTEM Micro Therapeutics, Inc. d/b/a ev3 Neurovascular HCG Class II 2014-01-10
K132660 NERVE CUFF Cook Biotech Incorporated JXI Class II 2014-01-10
K133604 ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS The Anspach Effort, Inc. HBC Class II 2014-01-10
K131789 CEREBRALOGIK- AEEG Mennen Medical , Ltd. OMA Class II 2013-12-27
K132998 WANDY SELF-ADHESIVE ELECTRODES Wandy Rubber Industrial Co., Ltd. GXY Class II 2013-12-20
K131933 ELECTRONIC PULSE MASSAGER Gurin Products, LLC NUH Class II 2013-12-20
K132952 MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) MicroVention, Inc. HCG Class II 2013-12-19
K132264 PRIMADO2 TOTAL SURGICAL SYSTEM Nakanishi, Inc. HBC Class II 2013-12-17
K131792 SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY Synthes, Inc. GXQ Class II 2013-12-16
K121248 LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC Moller Medical GmbH JXG Class II 2013-12-13
DEN130022 NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR Eneura Therapeutics OKP Class II 2013-12-13
K131586 CANARY BREATHING SYSTEM Palo Alto Health Sciences, Inc. HCC Class II 2013-12-10
K131851 OSTEOMED NEURO RONGEUR Osteomed HAE Class II 2013-12-06
K131383 X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE Advanced Brain Monitoring, Inc. GWQ Class II 2013-11-27
K132588 ADHESIVE ELECTRODES Top-Rank Health Care Equipment Co., Ltd. GXY Class II 2013-11-22
K132306 PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE Persyst Development Corp. OMB Class II 2013-11-21
K131921 ELECTRONIC PULSE STIMULATOR Shenzhen Jingkehui Electronic Co.., Ltd. NUH Class II 2013-11-15
K122410 I RUNE (I-200L) Medirune Co, Ltd. NUH Class II 2013-11-12
K131767 ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM Orthosensor, Inc. ONN Class II 2013-11-08
K130387 ORTHOALIGN PLUS SYSTEM Orthalign, Inc. OLO Class II 2013-11-08
K123958 JIAJIAN POINTOSELECT DIGITAL Wuxi Jiajian Medical Instrument Co., Ltd. GZJ Class II 2013-10-28
K130529 RAUMEDIC-PTO-MONITORING-SYSTEM Raumedic AG GWM Class II 2013-10-25
K131214 CRANIAL MAP NEURO Stryker Corporate HAW Class II 2013-10-18
K131775 UNIVERSAL NEURO 3 SYSTEM Stryker GWO Class II 2013-10-17
K132482 BARRICADE EMBOLIZATION COIL SYSTEM Blockade Medical HCG Class II 2013-10-10
K131015 BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT Cook Biotech, Inc. GXQ Class II 2013-10-08
K131948 MICROPLEX COIL SYSTEM (MCS) MicroVention, Inc. HCG Class II 2013-10-04
K131251 TRINITY ELE Carol Cole Company NFO Class II 2013-10-01
K132044 CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM Neos Surgery S.L GXR Class II 2013-09-30
K130874 STRYKER NAV3I PLATFORM Stryker Corporate HAW Class II 2013-09-27
K130150 TCM MASSAGER Anhui Jinjianqiao Med-Tech Co,. , Ltd. NUH Class II 2013-09-26
K132317 MICROPLEX COIL SYSTEM (MCS), VFC MicroVention, Inc. HCG Class II 2013-09-20
K122711 FACIAL SPA Nuskin NFO Class II 2013-09-17
K130802 OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) Shenzhen Dongdixin Technology Co., Ltd. NUH Class II 2013-09-16
K123866 TANYX Medecell Us, Inc. NUH Class II 2013-09-13
K131681 EYESEECAM VHIT Interacoustics A/S GWN Class II 2013-09-06

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