meddevicedb.com FDA Device Reference

Review Panel

Neurology FDA 510(k) Clearances & Devices

Cleared Devices
6,130
Product Codes (page)
37
Latest Decision
2002-02-07

Clearances · page 37 of 62

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K012589 FAST SET PUTTY Synthes (Usa) GXP Class II 2002-02-07
K013719 BECKER BAND CRANIAL REMOLDING ORTHOSIS Becker Orthopedic Appliance Co. MVA Class II 2002-02-05
K012463 LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL Everyway Medical Instruments Co.,Ltd GXY Class II 2002-02-05
K013700 ORTHOSIS HELMET MOLDING Precision Prosthetics & Orthotics, Inc. MVA Class II 2002-02-05
K012985 MATRIX DETACHABLE COILS Boston Scientific, Target HCG Class II 2002-01-31
K020032 APEX MEDICAL MINI TENS Apex Medical Corp. GZJ Class II 2002-01-31
K013167 MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500 Newcare Products, LLC GZJ Class II 2002-01-30
K011736 DRG QUICKMIX Doctor'S Research Group, Inc. GXP Class II 2002-01-30
K014012 DOC BAND Cranial Technologies, Inc. OAN Class II 2002-01-28
K012937 KNEE MODULE FOR THE STEALTHSTATION SYSTEM Medtronic Surgical Navigation Technologies HAW Class II 2002-01-25
K013091 ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM Von Zeppelin GmbH HBB Class II 2002-01-25
K013507 COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH Cosmo Health, Inc. GZJ Class II 2002-01-25
K013120 PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 Medamicus, Inc. GZB Class II 2002-01-24
K013459 MODIFICATION OF NC-STAT Neurometrix, Inc. JXE Class II 2002-01-17
K012804 PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS Scott E Allen CP MVA Class II 2002-01-17
K014146 84 CHANNEL EEG Xltek GWQ Class II 2002-01-14
K013450 NOTTA AMBULATORY RECORDER Stellate Systems OLV Class II 2002-01-14
K014147 80 CHANNEL EEG Xltek GWQ Class II 2002-01-14
K013389 DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES Datex-Ohmeda OLW Class II 2002-01-10
K011842 SABRE COMPAC Sle Limited GWJ Class II 2002-01-08
K011691 KIMSTIM AURICULAR ELECTRODE Kim Institute For Rehabilitation Medicine, P.C. GXY Class II 2001-12-27
K012569 MODIFICATION TO: INJECTABLE MIMIX Biomet, Inc. GXP Class II 2001-12-21
K011702 VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX Vertis Neuroscience, Inc. NHI Class II 2001-12-21
K011255 3D LINE STEROTACTIC HARDWARE ACCESSORIES 3D Line USA, Inc. HAW Class II 2001-12-20
K012415 AURIS AEP Synapsys, Inc. GWJ Class II 2001-12-18
K013813 MODIFICATION TO:APEX MEDICAL IF-4100 Apex Medical Corp. GXY Class II 2001-12-14
K004008 STRESS GUARD, MODEL HERDEV1 Herbo Medex International, Inc. GZJ Class II 2001-12-13
K010388 SONDREX P.A.L. SYSTEM Ohmeda Medical HCC Class II 2001-12-11
K013063 GRIP LOCK ANCHOR, MODEL 411374 Medtronic Neurological GZB Class II 2001-12-11
K013050 THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM Bioplate, Inc. GXN Class II 2001-12-10
K013060 ICS MEDICAL MODEL VG-30 VIDEO GOGGLES Ics Medical GWN Class II 2001-12-10
K013861 MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE Elekta Instrument AB HAW Class II 2001-12-06
K013000 MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520 Medtronic Neurosurgery GXN Class II 2001-12-05
K012380 MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY Stryker Leibinger HAW Class II 2001-12-03
K012920 MOLDED CRANIAL HELMET Fairview Orthopedic Laboratory MVA Class II 2001-11-28
K013136 ANEURYSM CLIPS Gistlstrasse HCH Class II 2001-11-26
K012830 LERMAN & SON CRANIAL ORTHOSIS HELMET Lerman & Son MVA Class II 2001-11-20
K012850 RECORDING AND STIMULATING ELECTRODE Radionics, A Division of Tyco Healthcare Group LP GZL Class II 2001-11-19
K013082 MEDSTAR 100 INTERFERENTIAL STIMLATOR Mednet Services, Inc. LIH Class II 2001-11-16
K012823 MODIFICATION TO HANDMASTER Ness-Neuromuscular Electrical Stimulation Systems GZI Class II 2001-11-14
K013399 MODEL MES-9000/EMG SYSTEM Myotronics-Noromed, Inc. HCC Class II 2001-11-13
K011812 SPECTRUM VENTRICULAR CATHETER Cook, Inc. NHC Class II 2001-11-08
K010202 OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES Leslie W. Organ GXD Class II 2001-10-31
K013257 HEMI-ARC SURGICAL NAVIGATOR Nuvasive, Inc. HAW Class II 2001-10-30
K013458 CRANIAL HELMET Children'S Hospital MVA Class II 2001-10-29
K012145 MICROPLEX COIL SYSTEM MicroVention, Inc. HCG Class II 2001-10-29
K012643 APEX MEDICAL LCD TENS-VII Apex Medical Corp. GZJ Class II 2001-10-29
K012848 WINNER CM4 COMBINATION UNIT Rich-Mar Corp. GZJ Class II 2001-10-25
K012719 NAVIGUS II MR Image-Guided Neurologics, Inc. HAW Class II 2001-10-22
K012457 SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) Sodemsystems HBC Class II 2001-10-22
K012453 SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) Sodemsystems HBC Class II 2001-10-22
K013137 ALGO 3 NEWBORN HEARING SCREENER Natus Medical, Inc. GWJ Class II 2001-10-16
K012384 EAR MUFFINS Bio-Logic Systems Corp. HCC Class II 2001-10-15
K010997 PAM-RL Individual Monitoring Systems, Inc. GWQ Class II 2001-10-15
K010615 CYCLOTEC AMT CTI TENS DEVICE Cyclotec GZJ Class II 2001-10-12
K012011 MODIFICATION TO A620 EEG Stoelting Co. HCC Class II 2001-10-10
K012886 CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE Cbyon, Inc. HAW Class II 2001-10-09
K012140 COM-PATCH Apex Medical Corp. GXY Class II 2001-10-05
K013025 MODIFICATION TO FLOUROLAB PLUS Z-Kat, Inc. HAW Class II 2001-10-03
K011794 XLTEK LED GOGGLES, MODEL LED-01 Excel Tech. , Ltd. GWE Class II 2001-10-01
K012466 BIS/EEG MODULE General Electric Medical Systems Information Techn OLW Class II 2001-10-01
K012366 NAVIGUS II TRAJECTORY GUIDE Image-Guided Neurologics, Inc. HAW Class II 2001-10-01
K003322 CODMAN BACTISEAL CATHETERS Codman & Shurtleff, Inc. HCA Class II 2001-10-01
K011017 PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT Rehabilicare, Inc. GZJ Class II 2001-09-24
K012814 COLLAGEN NERVE CUFF Collagen Matrix, Inc. JXI Class II 2001-09-21
K011964 INSIGHT MILLENNIUM PLUS Fasstech HCC Class II 2001-09-20
K010981 GSA GENITO SENSORY ANALYZER Medoc Ltd. Advanced Medical Systems LLN Class I 2001-09-20
K011241 NEUROSOFT'S SOURCE Neurosoft, Inc. OLX Class II 2001-09-19
K012007 RHS HELMET Restorative Health Svs, Inc. MVA Class II 2001-09-19
K012079 GEODESIC EEG SYSTEM, MODEL 200 Electrical Geodesics, Incorporated GWQ Class II 2001-09-19
K010602 VECTORVISION HIP Brainlab AG HAW Class II 2001-09-12
K010612 VECTORVISION KNEE Brainlab AG HAW Class II 2001-09-06
K012564 MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM Brainlab AG HAW Class II 2001-09-06
K011387 NEUROTHERM, MODEL JK4 Eurolink, LLC GXI Class II 2001-09-06
K010431 LEAD-LOK REUSABLE TENS/ NMES ELECTRODES Lead-Lok, Inc. GXY Class II 2001-09-06
K011823 BIOREHAB SYSTEM Nicolet Biomedical, Inc. HCC Class II 2001-09-06
K011543 TENS CARE, MODEL XL-Y3 Tenscare, Ltd. GZJ Class II 2001-08-31
K010204 STRYKER NAVIGATION SYSTEM-KNEE MODULE Stryker Corp. HAW Class II 2001-08-31
K011775 MICRO TARGETING DRIVE SYSTEM FHC, Inc. HAW Class II 2001-08-30
K011983 INSIGHT GENESIS Fasstech HCC Class II 2001-08-30
K010968 VECTORVISION CT/FLUORO Brainlab AG HAW Class II 2001-08-30
K010203 ACCU-PULSE TENS UNIT Sadler Electronics GZJ Class II 2001-08-28
K011746 MB 11 Maico Diagnostic GmbH GWJ Class II 2001-08-24
K003924 MAVIDON MEDICAL ELECTRODE JELLY Mavidon Medical Products GYB Class II 2001-08-24
K011992 FHC MICROTARGETING DRIVE SYSTEM FHC, Inc. HAW Class II 2001-08-14
K003631 SMARTWAVE IF 2000 Newwave Medical, LLC LIH Class II 2001-08-10
K011935 REJUVENIQUE MODEL #RJV10 Salton, Inc. NFO Class II 2001-08-08
K011444 ANSPACH EMAX DRILL SYSTEM The Anspach Effort, Inc. HBC Class II 2001-08-08
K002832 CONDUCTIVE GEL FOR ULTRASOUND Skylark Device & Systems Co., Ltd. GYB Class II 2001-08-06
K011397 PERSYST REVEAL Persyst Development Corp. OMB Class II 2001-08-03
K010295 MICROSTIM 100I TENS DEVICE Microstim, Inc. GZJ Class II 2001-08-03
K011971 NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 Image-Guided Neurologics, Inc. HAW Class II 2001-08-03
K012085 SOMNO STAR & SERIES SLEEP SYSTEM Sensor Medics Corp. OLV Class II 2001-08-02
K010908 MEDICON TITANIUM YASARGIL ANEURYSM CLIPS Medicon EG HCH Class II 2001-08-01
K010300 MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION Medtronic Vascular GZB Class II 2001-08-01
K010910 MEDICON YASARGIL CLIP APPLYING FORCEPS Medicon EG HCI Class II 2001-08-01
K012069 MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT Neurotron Medical, Inc. JXE Class II 2001-08-01
K012219 SCALPFIX CLIP SYSTEM Aesculap, Inc. HBO Class II 2001-07-31
K002874 WELL-TENS Well-Life Consultant GZJ Class II 2001-07-27
K010270 TREMOROMETER Flexable Systems, Inc. GYD Class II 2001-07-25

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