meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
30
Latest Decision
2002-09-09

Clearances · page 36 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K013705 ACT III VENTRICULAR CATHETER Innerspace, Inc. GWM Class II 2002-09-09
K022735 MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT MicroVention, Inc. HCG Class II 2002-09-06
K020360 ABR-2000 Meridian Co., Ltd. GZO Class II 2002-08-29
K021807 GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM Grass Instrument Co. OLV Class II 2002-08-29
K021760 NAVITRACK SYSTEM-OPTICAL TKR CT-LESS, MODEL 900.120 Orthosoft, Inc. HAW Class II 2002-08-27
K020400 DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR Meps, LLC GWF Class II 2002-08-23
K021986 BRAINET Nicolet Biomedical, Inc. GXY Class II 2002-08-23
K022554 MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM Integra Neurosciences JXG Class II 2002-08-23
K022427 CONTOUR SE MICROSPHERES Boston Scientific Corp HCG Class II 2002-08-22
K013532 ULTRASTIM KIT Axelgaard Mfg. Co., Ltd. GZJ Class II 2002-08-22
K013759 MSS-28CS-301/701 NEEDLESCOPE Olympus Optical Co., Ltd. GWG Class II 2002-08-20
K022553 CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L Integra Neurosciences GWM Class II 2002-08-20
K022460 SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS Smith & Nephew, Inc. HAW Class II 2002-08-19
K022414 STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE Medtronic Surgical Navigation Technologies HAW Class II 2002-08-14
K022074 SPHERZ I.Z.I. Corp. HAW Class II 2002-08-13
K021599 96 CHANNEL EEG HEADBOX MODEL EMU96 Excel Tech. , Ltd. GWQ Class II 2002-08-13
K022197 SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY The Electrode Store, Inc. GXY Class II 2002-08-13
K022405 MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC Rehabilicare, Inc. GZJ Class II 2002-08-12
K022222 LAMITRODE S-SERIES (S4 AND S8) LEADS Advanced Neuromodulation System,Inc GZB Class II 2002-08-08
K013396 ALPHA DRIVE SYSTEM Alpha Omega , Ltd. HAW Class II 2002-08-07
K021481 BRESAGEN CATHETER, MODEL CS-3000 Bresagen, Inc. HCA Class II 2002-08-06
K021496 HMS-DHR-3 NEUROMUSCULAR STIMULATOR Home Medical Services GZJ Class II 2002-08-06
K021644 PERF (OMMAYA STYLE) RESERVOIRS Phoenix Biomedical Corp. JXG Class II 2002-08-06
K021440 BONESOURCE HAC Stryker Instruments GXP Class II 2002-08-02
K011891 PANAG Panag International GZJ Class II 2002-07-30
K021436 TTECH MODEL 200E + TENS DEVICE Theratech, Inc. GZJ Class II 2002-07-30
K021408 RESORBABLE CRANIAL CLAMPS Synthes (Usa) GXR Class II 2002-07-29
K021604 MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 Ohio Medical Instrument Co., Inc. HBL Class II 2002-07-29
K021653 CODMAN BACTISEAL EVD CATHETER SET Codman & Shurtleff, Inc. JXG Class II 2002-07-29
K022121 PSG INPUT BOX, MODEL JE-912AK Nihon Kohden America, Inc. OLV Class II 2002-07-29
K020434 MICROPLEX COIL SYSTEM (MCS) MicroVention, Inc. HCG Class II 2002-07-29
K021918 CLARREN HELMET (ORTHOMERICA) Orthomerica Products, Inc. OAN Class II 2002-07-25
K021327 ORTHOPILOT HTO MODULE Aesculap, Inc. HAW Class II 2002-07-25
K020910 SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF The Electrode Store, Inc. GXZ Class II 2002-07-19
K014256 KOLIBRI IGS SYSTEMS Brainlab AG HAW Class II 2002-07-19
K021185 NERVUS MONITOR Taugagreining HF OLV Class II 2002-07-12
K020735 SOF-PACH REUSABLE NEUROSTIMULATION ELECTRODES Cathay International, Ltd. GXY Class II 2002-07-12
K014020 NT MEDITENS PLUS, TYPE 290 Bio-Medical Research, Ltd. GZJ Class II 2002-07-11
K021914 MICROPLEX COIL SYSTEMS (MCS) MicroVention, Inc. HCG Class II 2002-07-09
K021207 STARLIGHT Orthomerica Products, Inc. OAN Class II 2002-07-09
K020399 RESPERATE; MODEL RR-150 Intercure , Ltd. HCC Class II 2002-07-02
K021196 NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735 Neuron Therapeutics, Inc. JXG Class II 2002-07-01
K021221 O&P CRANICAL MOLDING HELMET Orthotic & Prosthetic Lab, Inc. MVA Class II 2002-07-01
K021895 BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM Bio-Logic Systems Corp. GWJ Class II 2002-07-01
K021869 OWL RADIOFREQUENCY SYSTEM, MODEL URF-2AP Diros Technology, Inc. GXD Class II 2002-07-01
K021050 KSEA NEUROENDOSCOPES AND ACCESSORIES KARL STORZ Endoscopy-America, Inc. GWG Class II 2002-06-26
K021144 SUBDURAL STRIP ELECTRODE Nicolet Biomedical, Inc. GYC Class II 2002-06-24
K020335 OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 Olympic Medical Corp. OMC Class II 2002-06-18
K013977 ECHO-SCREEN T, TA, TD, TDA, TC Fischer-Zoth Audiologic Systems, Inc. GWJ Class II 2002-06-14
K014113 ENDOMAP Siemens Medical Solutions USA, Inc. HAW Class II 2002-06-14
K021755 APEX MEDICAL DIGITAL TENS TS1211, TS1212 Apex Medical Corp. GZJ Class II 2002-06-12
K020803 CEFAR MEDICAL AB CEFAR PRIMO Cefar Medical AB GZJ Class II 2002-06-10
K021518 PAINDOC Advanced Neuromodulation Systems GZB Class II 2002-06-06
K021494 GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 Boston Scientific, Target HCG Class II 2002-06-06
K020764 NAVIPRO Kinamed, Inc. HAW Class II 2002-06-03
K020736 TRAATEK COTTONOID PATTIES Traatek, Inc. HBA Class II 2002-06-03
K020033 MAXISTAT PVA FOAM EMBOLIZATION PARTICLES Surgica Corp. HCG Class II 2002-05-31
K021118 DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570 Class A Ent. GXZ Class II 2002-05-28
K020846 ULTIMA TENS XL-A1 Tenscare, Ltd. GZJ Class II 2002-05-21
K020298 GALILEO CAS/NAV TKR SYSTEM Plus Orthopedics HAW Class II 2002-05-20
K020780 TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP Medex, Inc. GWM Class II 2002-05-20
K020516 CARE IFC PLUS Care Rehab, Inc. LIH Class II 2002-05-16
K021215 BIO-LOGIC ABAER CUB Bio-Logic Systems Corp. GWJ Class II 2002-05-15
K020445 THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG The Electrode Store, Inc. GXY Class II 2002-05-10
K020354 BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL) Baylis Medical Co., Inc. GXD Class II 2002-05-03
K014126 SANIDAD HEALTH-UP TENS MP-73725 Roc Chinese-European Industrial Research Society GZJ Class II 2002-05-03
K020567 AKUPORT M1 Vibrant Health GZO Class II 2002-05-02
K020564 EAV KINDLING 2000S GSR DEVICE Virbrant Health GZO Class II 2002-04-30
K020568 AKUPORT M-2 Vibrant Health GZO Class II 2002-04-30
K020565 EAV COMBI-2 Vibrant Health GZO Class II 2002-04-30
K021359 DIGI-PRO TENS MODEL WL-2203 AND WL-2205 Well-Life Healthcare, Inc. GZJ Class II 2002-04-30
K003896 LYMPHA VISION-EXPERT Bexley Trading, Inc. GXY Class II 2002-04-24
K020218 SNAP EEG MONITOR Nicolet Biomedical, Inc. OLW Class II 2002-04-22
K020468 CHIN ELECTRODE Dymedix, Inc. GXY Class II 2002-04-16
K020448 STATIC CRANIOPLASTY ORTHOSIS Eastern Cranial Affiliates MVA Class II 2002-04-12
K020728 MIETHKE SHUNT SYSTEM Aesculap, Inc. HCA Class II 2002-04-05
K013210 TRUWAVE Dan Med, Inc. GZJ Class II 2002-04-04
K013569 ORTHOPILOT 2 Aesculap, Inc. HAW Class II 2002-04-04
K013428 MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM Ohio Medical Instrument Co., Inc. HAW Class II 2002-04-04
K020667 CODMAN HAKIM SHUNT SYSTEMS Codman & Shurtleff, Inc. JXG Class II 2002-03-28
K014268 NORAPAD PLAIN; NORAPAD TA Perlei Medical, Inc. HBA Class II 2002-03-27
K013488 SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 Sophysa SA JXG Class II 2002-03-27
K020558 LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE Integra Neurosciences GWM Class II 2002-03-21
K020180 RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL Woodside Biomedical, Inc. GZJ Class II 2002-03-21
K020069 MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM Medtronic Midas Rex HBB Class II 2002-03-18
K014149 PAEDISCOPE, MODEL # P010A AND PF011A Aesculap, Inc. GWG Class II 2002-03-18
K020437 CLASSIC TENS Care Rehab, Inc. GZJ Class II 2002-03-15
K012448 VECTORVISION TRAUMA Brainlab AG HAW Class II 2002-03-14
K013005 ACT 11 MP VENTRICULAR CATHETER Innerspace, Inc. HCA Class II 2002-03-08
K014041 TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM Cordis Neurovascular HCG Class II 2002-03-07
K014060 MICROAIRE 1000E SYSTEM Microaire Surgical Instruments, Inc. HBE Class II 2002-03-05
K011030 AESCULAP -MIETHKE SHUNT SYSTEM Aesculap, Inc. JXG Class II 2002-03-01
K020338 STEALTHSTATION WITH FLUOROMERGE SOFTWARE Medtronic Surgical Navigation Technologies HAW Class II 2002-02-27
K003744 ENRAF-NONIUS ENDOMED 182 SYSTEM Henley Healthcare, Inc. GZJ Class II 2002-02-20
K013930 NEUROSENSOR Novus Monitoring, Ltd. GWM Class II 2002-02-20
K013863 CRYSTAL MONITOR MODEL 16 Cleveland Medical Devices, Inc. OMC Class II 2002-02-19
K012976 TWIN PLUS Grass-Telefactor Divison OLV Class II 2002-02-12
K012052 MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855 Medtronic PS Medical JXG Class II 2002-02-11
K020088 MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. GXN Class II 2002-02-08
K012938 SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS Smith & Nephew, Inc. HAW Class II 2002-02-08

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