meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
42
Latest Decision
2010-12-03

Clearances · page 26 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K101835 MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 Porex Surgical, Inc. HBW Class II 2010-12-03
K102842 ADHESIVE ELECTRODES Reno Medical Limited GXY Class II 2010-12-02
K100246 MAX-IF1000 Bio Protech, Inc. LIH Class II 2010-11-24
K102802 INTEGRA ELECTRODE TUNNELING NEEDLE Integra LifeSciences Corporation GYC Class II 2010-11-23
K101133 SENSOMETRICS SOFTWARE Dpcom AS GWM Class II 2010-11-18
K093054 SCALP DURA RETRACTOR, MODEL KS00474 KARL STORZ Endoscopy-America, Inc. GZT Class II 2010-11-15
K103003 AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM Aesculap, Inc. JXG Class II 2010-11-09
K102967 SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2 Smith & Newphew, Inc. OLO Class II 2010-11-04
K092477 NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 Neurowave Systems, Inc. OMC Class II 2010-10-29
K102523 MULTI-LEAD TRIALING CABLE MODEL 355531 Medtronic, Inc. GZB Class II 2010-10-26
K091393 ELEKTA NEUROMAG WITH MAXFILTER Elekta Neuromag OY OLX Class II 2010-10-26
K101235 CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM Neos Surgery S.L GXR Class II 2010-10-25
K100742 EXACTECH GPS Blue Ortho OLO Class II 2010-10-21
K102672 TARGET DETACHABLE COIL Boston Scientific Corp HCG Class II 2010-10-15
K101791 ROSA SURGICAL DEVICE Medtech S.A.S HAW Class II 2010-09-23
K102018 NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY Synthes USA Products, LLC GXP Class II 2010-09-23
K102021 CRYO-TOUCH II Myoscience, Inc. GXH Class II 2010-09-17
K100418 SUPERIOR STARBURST REUSABLE SELF-ADHERING TENS/NMES/FES STIMULATING ELECTRODE Covidien GXY Class II 2010-09-03
K102014 TENS STIMULATOR, MODELS 2800 AND 3000 Koalaty Products, Inc. GZJ Class II 2010-08-31
K102130 TENZING SYSTEM Mazor Surgical Technologies , Ltd. HAW Class II 2010-08-26
K101168 LEGEND POWER ADAPTER MODEL: 6475000 Medtronic Sofamor Danek HBB Class II 2010-08-24
K100912 DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE Kirwan Surgical Products, Inc. GXZ Class II 2010-08-19
K091692 AESCULAP PEEK CRANIOFIX Aesculap, Inc. GXR Class II 2010-08-12
K093304 PROTEKTOR 32 Natus Medical, Inc. GWF Class II 2010-08-11
K101691 LIFELINES PHOTIC STIMULATOR Lifelines , Ltd. GWE Class II 2010-08-10
K101372 DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 Baylis Medical Co., Inc. GXI Class II 2010-08-10
K100382 SALUTUNNEL NERVE PROTECTOR, MODEL ED-20329, ED-20330, ED-20331 Salumedica, LLC JXI Class II 2010-08-05
K093206 ORTHOMAP 3D 1.1 MODULE Stryker Corp. OLO Class II 2010-08-04
K101386 VIGILANT EEG MONITOR MODEL VIGILANT 2.0 Infinite Biomedical Technologies, LLC GWQ Class II 2010-07-30
K100958 MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES Baxano, Inc. HAE Class II 2010-07-23
K100441 XINIWAVE, MODEL XW-18 International Trade Group, Inc. NUH Class II 2010-07-15
K100038 DISPOSABLE REFLECTIVE MARKER SPHERES Brainlab AG HAW Class II 2010-07-14
K092573 NIHON KOHDEN QP-160AK EEG TREND PROGRAM Nihon Kohden America, Inc. OMA Class II 2010-07-09
K100661 EARPROBE Path Medical GmbH GWJ Class II 2010-07-01
K092625 WAVESTATE NEUROMONITOR Wavestate, Inc. ORT Class II 2010-06-29
K100447 MYOSCIENCE CRYO-TOUCH Myoscience, Inc. GXH Class II 2010-06-25
K100399 4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A Well-Life Healthcare Limited GZJ Class II 2010-06-25
K100836 CLEARPOINT SYSTEM Surgivision, Inc. ORR Class II 2010-06-16
K093949 OLYMPIC BRAINZ MONITOR MODEL OBM70001 Natus Medical, Inc. OMA Class II 2010-06-16
K100233 SUDOSCAN Impeto Medical GZO Class II 2010-06-14
K090608 MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B) Minta Medical Limited GXI Class II 2010-06-14
K093118 BRAINLAB KNEE ARTHROSCOPY Brainlab AG OLO Class II 2010-06-11
K092117 SCENAR, MODEL 10 Ritm Okb Zao GZJ Class II 2010-05-28
K093973 TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM Codman & Shurtleff, Inc. HCG Class II 2010-05-26
K094054 MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE Nuvasive, Inc. GWF Class II 2010-05-14
K092467 VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED Brainlab AG HAW Class II 2010-05-06
K093728 BE MICRO, TREA Eb Neuro S.P.A. OLV Class II 2010-04-29
K100454 HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V MicroVention, Inc. HCG Class II 2010-04-22
K094018 LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES Biocompatibles UK Limited HCG Class II 2010-04-16
K100116 LASERTOUCHONE (OTC) Laser Health Technologies, LLC NUH Class II 2010-04-15
K093361 SYNTHES AIR PEN DRIVE (APD) SYSTEM Synthes (Usa) HBB Class II 2010-04-14
K100683 NEUROLINK IP MODEL: PK1117 Natus Medical Incorporated GWQ Class II 2010-04-09
K100599 CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM Orthosoft, Inc. OLO Class II 2010-04-05
K100314 IMNS MEDACTA NAVIGATION SYSTEM,33.221000US Medacta International S.A. HAW Class II 2010-03-31
K092448 HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 Hivox Biotek, Inc. GZJ Class II 2010-03-30
K093494 LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM Pathfinder Therapeutics, Inc. OEW Class II 2010-03-30
K091940 MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION Tonica Elektronik A/S GWF Class II 2010-03-26
K093998 KNEEALIGN SYSTEM WITH REFERENCE SENSOR Orthalign, Inc. OLO Class II 2010-03-22
K092699 NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 Neurotronics, Inc. GWL Class II 2010-03-18
K083803 FIXIT HEADREST CLAMP SYSTEM Medicon EG HBL Class II 2010-03-10
K092675 GRINDCARE Medotech A/S HCC Class II 2010-03-03
K093425 MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA Mako Surgical Corp. OLO Class II 2010-02-24
K100107 SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 Smith & Nephew, Inc. OLO Class II 2010-02-23
K090019 NATUS NEUROWORKS, MODEL 104196 Natus Medical, Inc. OMB Class II 2010-02-22
K092227 JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS Integra Lifesciences Corp. HAE Class II 2010-02-17
K092192 WAYPOINT STEREOTACTIC SYSTEM FHC, Inc. HAW Class II 2010-02-12
K091757 OTC TENS FOR ARM AND LEG PAIN RELIEF, MODEL WL-2407 Well-Life Healthcare Limited NUH Class II 2010-02-05
K093142 TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM Boston Scientific Corp HCG Class II 2010-02-04
K092828 STATNET, MODEL 3100 Hydrodot, Inc. GXY Class II 2010-01-29
K093968 OSV II LOW FLOW LOW PRO VALVE Integra LifeSciences Corporation JXG Class II 2010-01-22
K091328 SIPHONX GRAVITATIONAL ANTISIPHON DEVICE Sophysa SA JXG Class II 2010-01-22
K093185 OWL UNIVERSAL RF SYSTEM URF-3AP (ML) Diros Technology, Inc. GXD Class II 2010-01-22
K092388 DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO Integra LifeSciences Corporation GXQ Class II 2010-01-21
K093919 MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V MicroVention, Inc. HCG Class II 2010-01-21
K090953 TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK Praxim Medivision, SA OLO Class II 2010-01-21
K093358 MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V MicroVention, Inc. HCG Class II 2010-01-15
K093223 COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG Compumedics Limited GWQ Class II 2010-01-15
K092780 INF 4160 PLUS, MODEL D-FJ31F Fuji Dynamics Limited LIH Class II 2010-01-07
K090341 MICHIGAN CRANIAL RESHAPING ORTHOSIS Danmar Products, Inc. MVA Class II 2010-01-06
K092371 SWIFT-LOCK ANCHOR, MODEL 1192 Advanced Neuromodulation Systems GZB Class II 2009-12-23
K091762 DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE Covidien GXY Class II 2009-12-22
K092546 GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM Gmdasz Manufacturing Co., Ltd. GXY Class II 2009-12-18
K091045 SMART TENS, MODEL: D-BC05T Body Clock Health Care, Ltd. GZJ Class II 2009-12-18
K091457 NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM Nexstim OY GWF Class II 2009-12-08
K083371 NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) Natus Medical, Inc. GWF Class II 2009-12-08
K092793 MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 Bio-Medical Research, Ltd. GXY Class II 2009-12-07
K090889 EMSI GARMENT ELECTRODES Emsi GXY Class II 2009-12-04
K092395 OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM Integra Lifesciences Corp. JXG Class II 2009-11-19
K092239 ROSA SURGICAL DEVICE, MODEL ROSA 1.1 Medtech S.A HAW Class II 2009-11-17
K091382 KRYPTONITE BONE CEMENT Doctors Research Group, Inc. GXP Class II 2009-11-16
K091963 VIGILANT EEG MONITOR, VIGILANT 2.0 Infinite Biomedical Technologies, LLC OLT Class II 2009-11-06
K092990 AMD 6605 TENS/NMES Advantageous Medical Devices, LLC GZJ Class II 2009-10-23
K093183 BIS QUATRO SENSOR Aspect Medical Systems, Inc. GXY Class II 2009-10-23
K090866 NEUROCALM MODEL 1 AND 2 Neuromed Devices, Inc. GZJ Class II 2009-10-21
K090474 ORTHOREX INTRA-OPERATIVE LOAD SENSOR Orthosensor, Inc. ONN Class II 2009-10-19
K092039 IDENTEVENT, VERSION 1.0G Optima Neuroscience, Inc. OMB Class II 2009-10-16
K092337 PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS Baylis Medical Co., Inc. GXI Class II 2009-10-16
K090190 WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM Nuclemed S.A. HAW Class II 2009-10-09
K092763 IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D Well-Life Healthcare Limited LIH Class II 2009-10-08
K092666 INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250 Boston Scientific Corp HCG Class II 2009-09-30

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