| MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE (K013861) | Elekta Instrument AB | 2001-12-06 |
| MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520 (K013000) | Medtronic Neurosurgery | 2001-12-05 |
| MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY (K012380) | Stryker Leibinger | 2001-12-03 |
| MOLDED CRANIAL HELMET (K012920) | Fairview Orthopedic Laboratory | 2001-11-28 |
| ANEURYSM CLIPS (K013136) | Gistlstrasse | 2001-11-26 |
| LERMAN & SON CRANIAL ORTHOSIS HELMET (K012830) | Lerman & Son | 2001-11-20 |
| RECORDING AND STIMULATING ELECTRODE (K012850) | Radionics, A Division of Tyco Healthcare Group LP | 2001-11-19 |
| MEDSTAR 100 INTERFERENTIAL STIMLATOR (K013082) | Mednet Services, Inc. | 2001-11-16 |
| MODIFICATION TO HANDMASTER (K012823) | Ness-Neuromuscular Electrical Stimulation Systems | 2001-11-14 |
| MODEL MES-9000/EMG SYSTEM (K013399) | Myotronics-Noromed, Inc. | 2001-11-13 |
| SPECTRUM VENTRICULAR CATHETER (K011812) | Cook, Inc. | 2001-11-08 |
| OWL RADIOFREQUENCY SYSTEM, MODEL URF-2A, AND ASSOCIATE RADIOFREQUENCY LESION PROBES (K010202) | Leslie W. Organ | 2001-10-31 |
| HEMI-ARC SURGICAL NAVIGATOR (K013257) | Nuvasive, Inc. | 2001-10-30 |
| CRANIAL HELMET (K013458) | Children'S Hospital | 2001-10-29 |
| MICROPLEX COIL SYSTEM (K012145) | MicroVention, Inc. | 2001-10-29 |
| APEX MEDICAL LCD TENS-VII (K012643) | Apex Medical Corp. | 2001-10-29 |
| WINNER CM4 COMBINATION UNIT (K012848) | Rich-Mar Corp. | 2001-10-25 |
| SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY) (K012457) | Sodemsystems | 2001-10-22 |
| SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY) (K012453) | Sodemsystems | 2001-10-22 |
| NAVIGUS II MR (K012719) | Image-Guided Neurologics, Inc. | 2001-10-22 |
| ALGO 3 NEWBORN HEARING SCREENER (K013137) | Natus Medical, Inc. | 2001-10-16 |
| EAR MUFFINS (K012384) | Bio-Logic Systems Corp. | 2001-10-15 |
| PAM-RL (K010997) | Individual Monitoring Systems, Inc. | 2001-10-15 |
| CYCLOTEC AMT CTI TENS DEVICE (K010615) | Cyclotec | 2001-10-12 |
| MODIFICATION TO A620 EEG (K012011) | Stoelting Co. | 2001-10-10 |
| CBYON SYSTEM WITH IMAGE ENHANCED FLUOROSCOPY MODULE (K012886) | Cbyon, Inc. | 2001-10-09 |
| COM-PATCH (K012140) | Apex Medical Corp. | 2001-10-05 |
| MODIFICATION TO FLOUROLAB PLUS (K013025) | Z-Kat, Inc. | 2001-10-03 |
| NAVIGUS II TRAJECTORY GUIDE (K012366) | Image-Guided Neurologics, Inc. | 2001-10-01 |
| CODMAN BACTISEAL CATHETERS (K003322) | Codman & Shurtleff, Inc. | 2001-10-01 |
| BIS/EEG MODULE (K012466) | General Electric Medical Systems Information Techn | 2001-10-01 |
| XLTEK LED GOGGLES, MODEL LED-01 (K011794) | Excel Tech. , Ltd. | 2001-10-01 |
| PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT (K011017) | Rehabilicare, Inc. | 2001-09-24 |
| COLLAGEN NERVE CUFF (K012814) | Collagen Matrix, Inc. | 2001-09-21 |
| GSA GENITO SENSORY ANALYZER (K010981) | Medoc Ltd. Advanced Medical Systems | 2001-09-20 |
| INSIGHT MILLENNIUM PLUS (K011964) | Fasstech | 2001-09-20 |
| NEUROSOFT'S SOURCE (K011241) | Neurosoft, Inc. | 2001-09-19 |
| RHS HELMET (K012007) | Restorative Health Svs, Inc. | 2001-09-19 |
| GEODESIC EEG SYSTEM, MODEL 200 (K012079) | Electrical Geodesics, Incorporated | 2001-09-19 |
| VECTORVISION HIP (K010602) | Brainlab AG | 2001-09-12 |
| NEUROTHERM, MODEL JK4 (K011387) | Eurolink, LLC | 2001-09-06 |
| VECTORVISION KNEE (K010612) | Brainlab AG | 2001-09-06 |
| MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM (K012564) | Brainlab AG | 2001-09-06 |
| BIOREHAB SYSTEM (K011823) | Nicolet Biomedical, Inc. | 2001-09-06 |
| LEAD-LOK REUSABLE TENS/ NMES ELECTRODES (K010431) | Lead-Lok, Inc. | 2001-09-06 |
| TENS CARE, MODEL XL-Y3 (K011543) | Tenscare, Ltd. | 2001-08-31 |
| STRYKER NAVIGATION SYSTEM-KNEE MODULE (K010204) | Stryker Corp. | 2001-08-31 |
| MICRO TARGETING DRIVE SYSTEM (K011775) | FHC, Inc. | 2001-08-30 |
| INSIGHT GENESIS (K011983) | Fasstech | 2001-08-30 |
| VECTORVISION CT/FLUORO (K010968) | Brainlab AG | 2001-08-30 |
| ACCU-PULSE TENS UNIT (K010203) | Sadler Electronics | 2001-08-28 |
| MAVIDON MEDICAL ELECTRODE JELLY (K003924) | Mavidon Medical Products | 2001-08-24 |
| MB 11 (K011746) | Maico Diagnostic GmbH | 2001-08-24 |
| FHC MICROTARGETING DRIVE SYSTEM (K011992) | FHC, Inc. | 2001-08-14 |
| SMARTWAVE IF 2000 (K003631) | Newwave Medical, LLC | 2001-08-10 |
| ANSPACH EMAX DRILL SYSTEM (K011444) | The Anspach Effort, Inc. | 2001-08-08 |
| REJUVENIQUE MODEL #RJV10 (K011935) | Salton, Inc. | 2001-08-08 |
| CONDUCTIVE GEL FOR ULTRASOUND (K002832) | Skylark Device & Systems Co., Ltd. | 2001-08-06 |
| MICROSTIM 100I TENS DEVICE (K010295) | Microstim, Inc. | 2001-08-03 |
| NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 (K011971) | Image-Guided Neurologics, Inc. | 2001-08-03 |
| PERSYST REVEAL (K011397) | Persyst Development Corp. | 2001-08-03 |
| SOMNO STAR & SERIES SLEEP SYSTEM (K012085) | Sensor Medics Corp. | 2001-08-02 |
| MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION (K010300) | Medtronic Vascular | 2001-08-01 |
| MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT (K012069) | Neurotron Medical, Inc. | 2001-08-01 |
| MEDICON YASARGIL CLIP APPLYING FORCEPS (K010910) | Medicon EG | 2001-08-01 |
| MEDICON TITANIUM YASARGIL ANEURYSM CLIPS (K010908) | Medicon EG | 2001-08-01 |
| SCALPFIX CLIP SYSTEM (K012219) | Aesculap, Inc. | 2001-07-31 |
| WELL-TENS (K002874) | Well-Life Consultant | 2001-07-27 |
| TREMOROMETER (K010270) | Flexable Systems, Inc. | 2001-07-25 |
| AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX (K010008) | Micronet Medical, Inc. | 2001-07-16 |
| MODEL 100 ACTIVITY MONITOR (K011429) | Telecom Medical, Inc. | 2001-07-13 |
| BIS ENGINE (K011834) | Aspect Medical Systems, Inc. | 2001-07-10 |
| SPINE WORKS COLLAR (K003662) | Spine Works | 2001-07-09 |
| STARBAND CRANIAL ORTHOSIS (K011350) | Orthomerica Products, Inc. | 2001-07-03 |
| AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR (K003759) | Aesculap, Inc. | 2001-06-28 |
| ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER (K010422) | Innerspace, Inc. | 2001-06-28 |
| A-LINE AEP MONITOR (K010965) | Alaris Medical Systems, Inc. | 2001-06-27 |
| NEUROGEN NERVE GUIDE (K011168) | Integra Lifesciences Corp. | 2001-06-22 |
| MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF (K011584) | Medtronic Vascular | 2001-06-22 |
| EMBOGOLD MICROSPHERE (K010026) | Biosphere Medical, Inc. | 2001-06-21 |
| MERIDIAN-PORTABLE (K010897) | Meridian Co., Ltd. | 2001-06-19 |
| ACTI-ICP MONITORING SYSTEM (K003905) | Innerspace, Inc. | 2001-06-15 |
| HANDMASTER (K010837) | Neuromusclar Electrical Stimulation Systems, Ltd. | 2001-06-15 |
| EEG MIS MONITOR MODEL # A-2000; BIS ENGINE (K011534) | Aspect Medical Systems, Inc. | 2001-06-15 |
| SELF-ADHESIVE ELECTRODES (K011411) | Pain Management Technologies | 2001-06-13 |
| ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL (K010209) | Biomedical Life Systems, Inc. | 2001-06-12 |
| BALLERT CRANIAL MOLDING HELMET (K011433) | Gema, Inc. | 2001-06-12 |
| MULTI-STIM, MODEL MS-100 (K001897) | Metron Medical Australia, Pty, Ltd. | 2001-06-12 |
| UNIQUE AMBULATORY EEG (K010697) | Axon Systems, Inc. | 2001-06-06 |
| CLARREN HELMET (K003035) | Children'S Hospital & Medical Center | 2001-06-06 |
| NEUROGRAPH EVOKED POTENTIAL SYSTEMS (EPS), MODEL EPS-1 (K010669) | Thuris Corp. | 2001-06-04 |
| ACTIWARE-PLMS (K011430) | Mini-Mitter Co., Inc. | 2001-05-31 |
| REBSTOCK YASARGIL ANEURYSM CLIP (K003500) | Rebstock - Instrumente GmbH | 2001-05-30 |
| DANMAR PRODUCTS MICHIGAN CRANIAL HELMET (K003630) | Danmar Products, Inc. | 2001-05-29 |
| KM-30 TENS ELECTRODE (K010543) | Katecho, Inc. | 2001-05-23 |
| HARMONE-SCHWARZER EEG SYSTEM (K010728) | Stellate Systems | 2001-05-21 |
| VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT (K003589) | Brainlab AG | 2001-05-21 |
| STEREOTACTIC FRAME BASED SYSTEM (K003486) | Stryker Instruments | 2001-05-17 |
| DYNATRON STS (K010565) | Dynatronics Corp. | 2001-05-15 |
| DYNATRON STS RX (K010948) | Dynatronics Corp. | 2001-05-15 |