| MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022 (K991502) | Medtronic PS Medical | 2000-09-12 |
| INSIGHT IMAGE GUIDED SURGICAL SYSTEM (K001642) | Surgical Insights, Inc. | 2000-09-12 |
| PARALLAX CRANIOSET (K994022) | Parallax Medical, Inc. | 2000-08-31 |
| 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128 (K000919) | Excel Tech. , Ltd. | 2000-08-31 |
| PSI SKULL CLAMP (K002276) | V. Mueller Neuro/Spine | 2000-08-29 |
| ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20 (K001588) | Arthrocare Corp. | 2000-08-17 |
| GDC ULTRASOFT COIL (K002181) | Boston Scientific, Target | 2000-08-11 |
| BIOTRACE, MODEL 1730 (K002063) | Bryan Corp. | 2000-08-10 |
| XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM (K992226) | Radionics, Inc. | 2000-08-04 |
| MICROTARGETING ELECTRODE (K991522) | FHC, Inc. | 2000-08-04 |
| DORO HEADREST SYSTEM (K001808) | Pro-Med Instruments GmbH | 2000-08-04 |
| NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 (K002053) | Orthosoft, Inc. | 2000-08-03 |
| POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE (K990100) | Te ME NA S.A.R.L. | 2000-08-02 |
| DA VINCHI EMG/EP ISA1004EP (K001467) | Airsep Corp. | 2000-08-01 |
| OPTICAL TRACKING SYSTEM (OTS) (K001950) | Radionics, Inc. | 2000-07-26 |
| KSEA BIPOLAR COAGULATING ELECTRODES (K001630) | Karl Storz Endoscopy | 2000-07-19 |
| SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS) (K001324) | Neuro Scan Labs | 2000-07-11 |
| OPI BAND (K001167) | Orthomerica Products, Inc. | 2000-07-07 |
| MEDISANA DIGITAL TENS (K994265) | Fuji Dynamics Limited | 2000-07-06 |
| FDTENS 2010 (K994266) | Fuji Dynamics Limited | 2000-07-06 |
| CRYSTAL-EEG MODEL 15 (K001110) | Cleveland Medical Devices, Inc. | 2000-07-05 |
| COMFORT STIM (K001117) | R & D Medical Products, Inc. | 2000-07-05 |
| WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) (K001103) | Excel Tech. , Ltd. | 2000-06-30 |
| XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4 (K001101) | Excel Tech. , Ltd. | 2000-06-30 |
| STEATHSTATION TREATMENT GUIDANCE PLATFORM (K001801) | Medtronic Surgical Navigation | 2000-06-30 |
| MODEL 4000 EEG MONITOR WITH PSI (PSA4000) (K001069) | Physiometrix, Inc. | 2000-06-30 |
| STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF (K001705) | Chester Labs, Inc. | 2000-06-29 |
| MODIFICATION TO NC-STAT (K000565) | Neurometrix, Inc. | 2000-06-27 |
| DATEX-OHMEDA EEG MODULE, M-EEG AND DATEX-OHMEDA EEG HEADBOX, N-EEG AND ACCESSORIES (K000892) | Datex-Ohmeda, Inc. | 2000-06-16 |
| ULTRASTIM ELECTRODE, MODEL US4040 (K000947) | Axelgaard Mfg. Co., Ltd. | 2000-06-16 |
| STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM (K001284) | Medtronic Surgical Navigation Technologies | 2000-06-12 |
| ENDOR 2000 (K984376) | T.C. Medical, Inc. | 2000-06-07 |
| SELF ADHERING NAVIGUS GUIDE (K001192) | Image-Guided Neurologics, Inc. | 2000-06-07 |
| INTERCURE LTD. RESPI-LOW (K000405) | Intercure , Ltd. | 2000-05-17 |
| MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) (K001431) | Radionics, Inc. | 2000-05-17 |
| MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY (K001013) | Airsep Corp. | 2000-05-16 |
| MODEL 4300 PSARRAY EEG ELECTRODE SET (K001055) | Physiometrix, Inc. | 2000-05-11 |
| RUMBAR DRAINAGE SYSTEM (K000514) | Phoenix Biomedical Corp. | 2000-05-10 |
| MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM (K001153) | Medtronic Surgical Navigation | 2000-05-03 |
| GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4 (K001083) | Boston Scientific, Target | 2000-05-03 |
| SHELHIGH NO-REACT DURA SHIELD (K982101) | Shelhigh, Inc. | 2000-05-02 |
| MEDTRONIC MODEL 7499 EXTENSION (K000445) | Medtronic Vascular | 2000-04-28 |
| EMBOSPHERE MICROSPHERES (K991549) | Biosphere Medical | 2000-04-26 |
| VITAPORT 3 (K000338) | Nihon Kohden America, Inc. | 2000-04-26 |
| CRANIAL DRILL (K000195) | Image-Guided Neurologics, Inc. | 2000-04-20 |
| QUIK-CAP (K000865) | Neuroscan | 2000-04-18 |
| EEG WITH VIDEO, MODEL EX-NW (K000898) | Excel Tech. , Ltd. | 2000-04-14 |
| MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM), (K000105) | Medtronic Vascular | 2000-04-12 |
| SIPHONGUARD CSF CONTROL DEVICE (K992173) | Johnson & Johnson Professionals, Inc. | 2000-04-07 |
| PACIFIC SURGICAL PATTIES (K993019) | V. Mueller Neuro/Spine | 2000-03-30 |
| RITA RF GENERATOR AND ACCESSORIES, MODEL 500 SERIES (K983214) | Rita Medical Systems | 2000-03-27 |
| NEUROTHERM RF CANNULA (K994344) | Rocket Medical Plc | 2000-03-21 |
| RADIONICS LUMBOPERITONEAL SHUNT (K000057) | Radionics, Inc. | 2000-03-20 |
| RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL (K994387) | Woodside Biomedical, Inc. | 2000-03-16 |
| CBYON SURGICAL OPERATING SYSTEM (SOS) (K000171) | Cbyon, Inc. | 2000-03-13 |
| CODMAN ETHISORB DURA PATCH (K991413) | Johnson & Johnson Professionals, Inc. | 2000-03-13 |
| COMPUMEDICS E-SERIES EEG SYSTEM (K000068) | Compumedics Neuro Science Pty , Ltd. | 2000-03-13 |
| MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L (K993568) | Machida Endoscope Co., Ltd. | 2000-03-13 |
| GRASS TS3201/6401 EEG AMPLIFIER SYSTEM (K994142) | Grass Instrument Co. | 2000-03-06 |
| MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA (K000073) | Mercury Medical | 2000-03-01 |
| MEDAMICUS EPIDURAL INTRODUCER (K994097) | Medamicus, Inc. | 2000-03-01 |
| SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION (K994421) | Surgical Navigation Specialists, Inc. | 2000-02-23 |
| LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM (K993990) | Stryker Instruments | 2000-02-22 |
| STEALTHSTATION TREATMENT GUIDANCE PLATFORM (K992461) | Surgical Navigation Technologies, Inc. | 2000-02-22 |
| VOYAGER 6.0 SOFTWARE OPTION (K000310) | Philips Medical Systems (Cleveland), Inc. | 2000-02-15 |
| TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS (K991397) | Sein Electronics Co., Ltd. | 2000-02-11 |
| SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T (K994191) | Nmt Medical, Inc. | 2000-02-08 |
| SD-730 IF-SDS, PERFECT PULSE IF-SDS (K992652) | Skylark Device & Systems Co., Ltd. | 2000-02-03 |
| NEUROCOMP (K993654) | Neurocybernetics | 2000-01-27 |
| NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY (K993622) | Alpha Omega , Ltd. | 2000-01-24 |
| FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL (K993418) | Boston Scientific, Target | 2000-01-21 |
| GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC) (K993417) | Boston Scientific, Target | 2000-01-21 |
| GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1 (K993415) | Boston Scientific, Target | 2000-01-21 |
| MSAS PROFESSIONAL (K993824) | Biomeridian, Int. | 2000-01-20 |
| STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX (K993239) | Stryker Corp. | 2000-01-18 |
| ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076 (K994330) | Aspect Medical Systems, Inc. | 2000-01-18 |
| BRAINLAB STEREOTACTIC ARC (K992916) | Brainlab | 2000-01-11 |
| MAGSTIM RAPID (K992911) | Magstim Corporation US | 2000-01-07 |
| PSI TITANIUM ANEURYSM CLIP (K991959) | V. Mueller Neuro/Spine | 2000-01-06 |
| STEALTHSTATION TREATMENT GUIDANCE PLATFORM (K992927) | Surgical Navigation Technologies, Inc. | 1999-12-29 |
| MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO. (K994149) | Bio-Logic Systems Corp. | 1999-12-27 |
| SODEM PERFORATOR DRIVE (K993851) | Sodemsystems | 1999-12-27 |
| GUGLIELMI DETACHABLE (GDC) (K991139) | Boston Scientific, Target | 1999-12-22 |
| SNN FLUORO NAVIGATION SYSTEM (K993673) | I.S.G. Technologies, Inc. | 1999-12-21 |
| MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE (K994175) | Sodemsystems | 1999-12-21 |
| EIM-107 PREP-CHECK (K993202) | General Devices | 1999-12-17 |
| ULTRA-GARMENT ELECTRODE (K993130) | Newwave Medical, LLC | 1999-12-17 |
| DCI ENDOSCOPE (K993539) | KARL STORZ Endoscopy-America, Inc. | 1999-12-15 |
| RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R (K983907) | Woodside Biomedical, Inc. | 1999-12-09 |
| VIRTUOSO-STEREOTAXIC PLANNING SOFTWARE (K991706) | Stryker Corp. | 1999-12-07 |
| BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG (K993708) | Biomagnetic Technologies, Inc. | 1999-12-03 |
| 3D1 MICROPOSITIONING HEADSTAGE (K993501) | Scientific Tools, Inc. | 1999-11-22 |
| MED-4000 (K993823) | Micro Current Technology, Inc. | 1999-11-19 |
| CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER (K990290) | Biomet, Inc. | 1999-11-18 |
| SABRE (K993177) | Sle Limited | 1999-11-16 |
| 1818 TENS UNIT (K992709) | 138 Medical Supplies, Inc. | 1999-11-09 |
| BRAVO MULTI-MODALITY SYSTEM (K991054) | Nicolet Biomedical, Inc. | 1999-11-03 |
| AXON MP-1 MICROPOSITIONER (K990683) | Axon Instruments, Inc. | 1999-11-03 |
| THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F (K992843) | Ohio Medical Instrument Co., Inc. | 1999-11-02 |
| AD-TECH'S FORAMEN OVALE ELECTRODE (K990788) | Ad-Tech Medical Instrument Corp | 1999-11-02 |