| LIFELINES TRACKIT (K010460) | Lifelines , Ltd. | 2001-05-14 |
| BIOFIND (K003480) | Bio-Scan, Inc. | 2001-05-11 |
| SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION (K010542) | Surgical Navigation Specialists, Inc. | 2001-05-08 |
| NEUROFAX, MODELS EEG-1100A, EEG-9100A (K011204) | Nihon Kohden America, Inc. | 2001-05-08 |
| MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 (K010361) | Medtronic PS Medical | 2001-05-07 |
| BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE) (K002565) | Baylis Medical Co., Inc. | 2001-05-03 |
| NEUROPLUS, MODEL A10040, A10041, A10042, A10043 (K010638) | Vermont Medical, Inc. | 2001-05-03 |
| MACROPORENS CRANILOC (K002334) | Macropore Biosurgery, Inc. | 2001-05-02 |
| TRANSAMERICAN TENS (K010782) | Transamerica Medical Systems | 2001-04-27 |
| CRANIAL MOLDING ORTHOSIS (K010273) | Orthotic Solutions, Inc. | 2001-04-25 |
| NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES (K010969) | Stryker Instruments | 2001-04-20 |
| MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, (K010341) | Medtronic PS Medical | 2001-04-20 |
| REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED) (K010086) | Excel Tech. , Ltd. | 2001-04-09 |
| XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP (PROPOSED) (K010092) | Excel Tech. , Ltd. | 2001-04-02 |
| REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED) (K010088) | Excel Tech. , Ltd. | 2001-03-26 |
| REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED) (K010089) | Excel Tech. , Ltd. | 2001-03-26 |
| XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED) (K010090) | Excel Tech. , Ltd. | 2001-03-26 |
| XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP (K010087) | Excel Tech. , Ltd. | 2001-03-19 |
| STERILE SUBDERMAL NEEDLE ELECTRODES (K010019) | Nicolet Biomedical, Inc. | 2001-03-19 |
| REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128-RP (K010084) | Excel Tech. , Ltd. | 2001-03-16 |
| EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) (K010085) | Excel Tech. , Ltd. | 2001-03-15 |
| LORENZ FIDUCAIL SCREW (K010427) | Walter Lorenz Surgical, Inc. | 2001-03-15 |
| YORAMED, MODEL T-202 (K002297) | United Yoram Distributors, Inc. | 2001-03-15 |
| MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM (K001353) | Biomedical Ent., Inc. | 2001-03-13 |
| MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) (K010548) | Radionics, A Division of Tyco Healthcare Group LP | 2001-03-12 |
| LIFECARE COMPACT TENS DEVICE (K003369) | Lifecare , Ltd. | 2001-03-08 |
| ENGPLUS (K010059) | Western Systems Research, Inc. | 2001-02-27 |
| MEDIVISION IGS SYSTEM (K003699) | Medivision (U.S.A.), Inc. | 2001-02-27 |
| ORTHOPILOT (K003347) | Kinamed, Inc. | 2001-02-23 |
| MICROTARGETING DRIVE SYSTEM (K003776) | FHC, Inc. | 2001-02-23 |
| Z-TOUCH (K003268) | Brainlab AG | 2001-02-22 |
| MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES (K003914) | Medtronic PS Medical | 2001-02-22 |
| MEDRELIEF (K003507) | Healthonics, Inc. | 2001-02-21 |
| MICROSPEED EC MOTORSYSTEM GD650/GD653 (K003612) | Aesculap, Inc. | 2001-02-20 |
| TENSCARE, MODEL TENS XL-2 (K003591) | Tenscare, Ltd. | 2001-02-14 |
| 64 CHANNEL EEG / MODEL NUMBER EX-NW-64 (K010150) | Excel Tech. , Ltd. | 2001-02-09 |
| REMVIEW SLEEP RECORDER, MODEL 320 (K003499) | Respironics, Inc. | 2001-02-09 |
| MULTI INTERFERENTIAL STIMULATOR, MODEL TR-841 (K993600) | Nisha Communication Industries | 2001-02-05 |
| CURRY MULTIMODAL NEUROIMAGING SOFTWARE (K001781) | Neurosoft, Inc. | 2001-02-05 |
| ANALGESIC PULSER, MODEL AP-439 (K993229) | Johari Electro-Tech Co. | 2001-02-02 |
| WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE (K002219) | Wandy Rubber Industrial Co., Ltd. | 2001-02-02 |
| WANDY SILICONE CONDUCTIVE RUBBER PAD (K002227) | Wandy Rubber Industrial Co., Ltd. | 2001-02-02 |
| EEG WITH VIDEO, MODEL EX-NW (K010091) | Excel Tech. , Ltd. | 2001-02-01 |
| EYETECT TREMOR MONITOR UNIT (TMU) (K003644) | Eyetect, LLC | 2001-02-01 |
| YASARGIL PERMANENT ANEURYSM CLIPS (K003519) | Aesculap, Inc. | 2001-01-29 |
| PVA FOAM EMBOLIZATION PARTICLES (K001678) | Surgica Corp. | 2001-01-25 |
| STIMATE N601 TENS (K003487) | Everyway Medical Instruments Co.,Ltd | 2001-01-24 |
| STRYKER REMOTE SURGICAL PLANNING SYSTEM (K004027) | Stryker Instruments | 2001-01-24 |
| RENEW NEUROSTIMULATION SYSTEM (K000852) | Advanced Neuromodulation Systems | 2001-01-19 |
| NC-STAT (K003508) | Neurometrix, Inc. | 2001-01-17 |
| MS-ONE, MODEL MS-1 (K003258) | Home Wellness West | 2001-01-12 |
| HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3 (K003231) | Home Medical Services | 2001-01-12 |
| MICRUS MICROCOIL DELIVERY SYSTEM, MDS03 (K002056) | Micrus Corp. | 2001-01-11 |
| MIZAR, BASIS BE, SANDMAN DIGITAL (K003154) | Eb Neuro S.P.A. | 2001-01-05 |
| ORION PLATINUM (K003367) | Srs Medical Systems, Inc. | 2001-01-04 |
| STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES (K003111) | Stryker Instruments | 2001-01-04 |
| REGAIN DESKTOP (K003127) | Srs Medical Systems, Inc. | 2001-01-04 |
| COMPUMEDICS SIESTA SYSTEM (K003175) | Compumedics Limited | 2000-12-27 |
| BIO-LOGIC SLEEPSCAN NETLINK (K003681) | Bio-Logic Systems Corp. | 2000-12-21 |
| HAKIM PROGRAMMER AND TRANSMITTER (K003564) | Codman & Shurtleff, Inc. | 2000-12-20 |
| AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A (K003038) | Agilent Technologies Deutschland GmbH | 2000-12-15 |
| ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS (K002985) | Ics Medical Corp. | 2000-12-13 |
| SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 (K002970) | Medical Designs, LLC | 2000-12-12 |
| STEALTHSTATION TREATMENT GUIDANCE PLATFORM (K003201) | Medtronic Surgical Navigation Technologies | 2000-12-12 |
| HANGER CRANIAL BAND (K001669) | Hanger Orthopedic Group, Inc. | 2000-12-08 |
| XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8 (K002969) | Xltek | 2000-12-08 |
| FLUOROLAB PLUS (K002893) | Z-Kat, Inc. | 2000-12-04 |
| SOFTSENS (K001521) | Integrated Biosensing Technologies | 2000-11-27 |
| LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE (K002765) | Integra Neurosciences | 2000-11-24 |
| SCAN LT40 (40 CHANNELS) (K001564) | Neuro Scan Labs | 2000-11-24 |
| DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM (K000651) | Cook, Inc. | 2000-11-24 |
| SALUMEDICA NERVE CUFF (K002098) | Salumedica, LLC | 2000-11-24 |
| NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 (K001692) | Neurosoft, Inc. | 2000-11-24 |
| MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 (K002572) | Medtronic PS Medical | 2000-11-16 |
| LUMBOPERITONEAL SHUNT SYSTEM (K002476) | Phoenix Biomedical Corp. | 2000-11-09 |
| KM-10 TENS ELECTRODE (K000870) | Katecho, Inc. | 2000-11-07 |
| VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 (K002990) | Vascular Technology Incorporated | 2000-11-06 |
| MERIDIAN-II AND MERDIAN-PLUS (K001347) | Meridian Co., Ltd. | 2000-11-03 |
| KSEA MINIATURE NEUROENDOSCOPE (K002704) | KARL STORZ Endoscopy-America, Inc. | 2000-11-03 |
| VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V (K002392) | Integra Neurocare, LLC | 2000-11-02 |
| CRANIOCAP (K000861) | Gillette Children'S Specialty Healthcare | 2000-10-30 |
| PHOENIX DIGITAL EEG (K002316) | Axon Systems, Inc. | 2000-10-26 |
| BURR HOLE COVER, MODEL XX (K001096) | Image-Guided Neurologics, Inc. | 2000-10-25 |
| ANSPACH ANGLED MICRONOSE ATTACHMENT (K002903) | The Anspach Effort, Inc. | 2000-10-24 |
| NEUROMAP WITH NEURO 100 (K002773) | Radionics, Inc. | 2000-10-23 |
| KSEA NEURO-FIBERSCOPE (K002788) | KARL STORZ Endoscopy-America, Inc. | 2000-10-23 |
| BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR CABLE/PMX-BAY-BAY (K002389) | Baylis Medical Co., Inc. | 2000-10-23 |
| ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG (K002631) | Eemagine Medical Imaging Solutions GmbH | 2000-10-23 |
| BIOSLEEP (K002622) | Oxford Biosignals Limited | 2000-10-23 |
| DA VINCHI EEG AND EMG/EP SYSTEMS (K000963) | Airsep Corp. | 2000-10-20 |
| NAVIGUS PEEL AWAY INTRODUCER (K002330) | Image-Guided Neurologics, Inc. | 2000-10-18 |
| MODIFICATION TO YASARGIL ANEURYSM CLIPS (K002871) | Aesculap, Inc. | 2000-10-13 |
| EEG SPIKE AND EVENT DETECTOR MODULE (K002332) | Excel Tech. , Ltd. | 2000-10-06 |
| ADVANTAGE DRIVE SYSTEM (K002523) | Linvatec Corp. | 2000-10-06 |
| STRYKER NAVIGATION SYSTEM - ENT MODULE (K002732) | Stryker Corp. | 2000-10-02 |
| ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110 (K001980) | Aspect Medical Systems, Inc. | 2000-09-27 |
| SOPHY SU8 PRESSURE ADJUSTABLE VALVE (K992465) | Sophysa SA | 2000-09-21 |
| BIS ENGINE (K002837) | Aspect Medical Systems, Inc. | 2000-09-19 |
| BIO-LOGIC CEEGRAPH NETLINK (K002570) | Bio-Logic Systems Corp. | 2000-09-14 |
| ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 (K002734) | Aspect Medical Systems, Inc. | 2000-09-14 |