| MODIFICATION TO GFX NERVE ABLATION SYSTEM (K081729) | Bioform Medical, Inc. | 2008-08-07 |
| DIGIMATCH ROBODOC SURGICAL SYSTEM (K072629) | Integrated Surgical Systems, Inc. | 2008-08-06 |
| TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES (K081232) | Praxim | 2008-08-06 |
| DERMABIOSAFE (K080298) | Complete Product Resources | 2008-08-05 |
| SELF-ADHESIVE ELECTRODES (K080276) | Cathay Health Care Equipment Manufacturing, Inc. | 2008-08-04 |
| JOINT STIM, MODEL 1000 (K073386) | Pain Management Technologies | 2008-07-30 |
| ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING (K081430) | Elekta Neuromag OY | 2008-07-28 |
| CINCH ANCHOR, MODEL 1194 (K081208) | Advanced Neuromodulation Systems | 2008-07-18 |
| PIGALILEO 4TH GENERATION SYSTEM (K080875) | Smith & Nephew, Inc. | 2008-07-18 |
| STRYKER POWER TOOL NAVIGATOR ATTACHMENT (K080450) | Stryker Corp. | 2008-07-17 |
| HYDROSOFT AND HYDROSOFT PLUS EMBOLIZATION COIL SYSTEMS (K080666) | MicroVention, Inc. | 2008-07-11 |
| ELECTRODE ARRAY CAP (K071446) | Electrode Arrays | 2008-07-02 |
| MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT (K080379) | Micrus Endovascular Corporation | 2008-06-30 |
| MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM (K071984) | Cma Microdialysis AB | 2008-06-27 |
| PRO TENS, MODEL WL-240 RX (K080304) | Well-Life Healthcare Limited | 2008-06-20 |
| FREMS SSC DISPOSABLE FOAM ELECTRODES, MODEL 800-000-057; FREMS SSC DISPOSABLE NON-WOVEN ELECTRODES, MODEL 800-000-058 (K080902) | Lorenz Biotech S.P.A. | 2008-06-13 |
| NERVE MONITORING CABLE (K073229) | Pioneer Surgical Technology | 2008-06-06 |
| UNI-KNEE 2.0 (K080678) | Brainlab AG | 2008-06-06 |
| COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE (K080386) | Columbia Scientific Development, LLC | 2008-05-30 |
| VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM (K081102) | Visionsense, Ltd. | 2008-05-29 |
| OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM (K073006) | Takiron Co., Ltd. | 2008-05-29 |
| SPINEASSIST SYSTEM (K073467) | Mazor Surgical Technologies , Ltd. | 2008-05-23 |
| ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 (K080547) | Aesculap Implant System, Inc. | 2008-05-23 |
| ELEXOMA MEDIC (K070412) | Redplane AG | 2008-05-21 |
| SHUNTCHECK - CSF SHUNT FLOW DETECTOR (K080168) | Neuro Diagnostic Devices | 2008-05-16 |
| SUBDERMAL NEEDLE ELECTRODES (K072276) | Xian Friendship Electronics Co., Ltd. | 2008-05-16 |
| LEKSELL SURGIPLAN, MODEL 1006947 (K080250) | Elekta Instrument AB | 2008-05-13 |
| KSEA CLEARVISION II, MODEL 40334120 (K072410) | KARL STORZ Endoscopy-America, Inc. | 2008-05-09 |
| MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF (K080437) | Micrus Endovascular Corporation | 2008-05-08 |
| TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT (K080967) | Cordis Neurovascular, Inc. | 2008-05-02 |
| DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES (K073532) | Technomed Europe | 2008-05-01 |
| EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL (K080802) | The Anspach Effort, Inc. | 2008-04-30 |
| MPS OXIPORT AND MPS OXIPORT PLUS (K072379) | Innerspace, Inc. | 2008-04-29 |
| NEUROMETRIX ADVANCE (K070109) | Neurometrix, Inc. | 2008-04-25 |
| TARGET STERILE ELECTRODE (K072799) | Vision Quest Industries, Inc. | 2008-04-24 |
| INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE (K070217) | Neuro Resource Group, Inc. | 2008-04-04 |
| VIVOSONIC NEUROSCREEN (K080060) | Vivosonic, Inc. | 2008-04-04 |
| CONMED LINVATEC OSPREY DRILL SYSTEM (K080444) | Conmed Linvatec | 2008-04-02 |
| MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES (K061907) | GE Healthcare | 2008-03-27 |
| AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL 021999 (K071120) | Aemed, Inc. | 2008-03-13 |
| KFH ENERGY, MODEL: E1 (K073008) | Kingfisher Healthcare NV | 2008-03-11 |
| TENS/IF 14 (K071869) | Emsi | 2008-03-07 |
| BAXANO ULTRA LOW PROFILE RONGEUR (K080494) | Baxano, Inc. | 2008-03-04 |
| SMART COUPLER, MODEL M015401 (K073384) | Intelligent Hearing Systems | 2008-02-28 |
| EEG NEUROAMP, MODEL CS10137 (K073557) | Corscience GmbH & Co. KG | 2008-02-28 |
| LIMITED ARTIFACT SKULL PIN, MODEL 0107 (K073163) | Dinkler Surgical Devices, Inc. | 2008-02-28 |
| MODIFICATION TO:NESS L300 (K080219) | Ness-Neuromuscular Electrical Stimulation Systems | 2008-02-28 |
| MICRUS MICROCOIL SYSTEMS (K073442) | Micrus Endovascular Corporation | 2008-02-26 |
| NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES (K073576) | Harod Enterprises, Inc. | 2008-02-22 |
| MODEL I-2000 MONITOR (K072382) | Infinite Biomedical Technologies | 2008-02-15 |
| PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES (K073419) | Rj Medical, Inc. | 2008-02-14 |
| PROSTIM 1000/2000 (K073438) | Bio Protech, Inc. | 2008-02-07 |
| ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 (K072899) | Aesculap Implant Systems, Inc. | 2008-02-06 |
| BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM (K073626) | Bio-Logic Systems Corp. | 2008-02-05 |
| VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM (K072254) | Interacoustics A/S | 2008-02-05 |
| HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE (K072123) | Biowave Corporation | 2008-02-01 |
| NTRAINER SYSTEM (K071866) | Kcbiomedix, Inc. | 2008-02-01 |
| SMALL LUMEN PERITONEAL CATHETER (K073139) | Medtronic Neurosurgery | 2008-01-30 |
| ALGO 5 NEWBORN HEARING SCREENER (K073665) | Natus Medical, Inc. | 2008-01-25 |
| MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) (K072806) | Mako Surgical Corp. | 2008-01-24 |
| BOSTON-BAND CRANIAL REMODLING ORTHOSIS (K072862) | Boston Brace Intl., Inc. | 2008-01-22 |
| EEG-1100A SWITCH BOX (K073491) | Nihon Kohden America, Inc. | 2008-01-11 |
| MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES (K071782) | Micromed S.P.A. | 2008-01-10 |
| HANGER CRANIAL BAND (K072566) | Hanger Prosthetics & Orthotics, Inc. | 2008-01-09 |
| CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 (K073336) | Codman & Shurtleff, Inc. | 2008-01-04 |
| REHASTIM & REHAMOVE (K073237) | Hasomed GmbH | 2007-12-27 |
| POLYBONE (K070012) | Kyung Won Medical Co., Ltd. | 2007-12-27 |
| GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) (K062580) | GE Healthcare | 2007-12-21 |
| STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 (K071482) | Synergetics, Inc. | 2007-12-20 |
| LINASYS (K071063) | Pathfinder Therapeutics, Inc. | 2007-12-20 |
| PATIENT CONTOURED MESH-PEEK (PCM-P) (K072707) | KLS-Martin L.P. | 2007-12-19 |
| STRYKER NAVIGATION SYSTEM INFINITUS HIP RESURFACING MODULE (K072271) | Stryker Corp. | 2007-12-18 |
| SYNTHES (USA) 2.0MM TITANIUM T-PLATE (K072758) | Synthes (Usa) | 2007-12-18 |
| OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT (K072601) | Osteosymbionics, LLC | 2007-12-10 |
| TOTAL HIP SURGETICS NAVIGATION SYSTEM (K072267) | Praxim S.A | 2007-12-10 |
| DELTA SCANNER, DELTA SCANNER PRO, DS SPINE PRO, DS SPORTS PRO AND DS REHAB (K071878) | Med-Lectric Corporation | 2007-12-07 |
| LIMITORR VOLUME LIMITING EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM, MODELS INS9020, INS9030 (K072929) | Integra LifeSciences Corporation | 2007-12-07 |
| NEURONAV SYSTEM AND NEURONAV DRIVE (K071697) | Alpha Omega , Ltd. | 2007-12-03 |
| THERAPEUTIC MASSAGE COMPANION (K060846) | Endurance Therapeutics | 2007-12-03 |
| EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR (K071624) | Everlife Medical Equipment Co., Ltd. | 2007-11-27 |
| NUFACE, MODEL NU-4003 (K072260) | Carol Cole Company | 2007-11-27 |
| RT300-S AND RT300-SP FES CYCLE ERGOMETER (K072398) | Restorative Therapies, Inc. | 2007-11-21 |
| BIS EEG VISTA MONITOR SYSTEM AND BISX (K072286) | Aspect Medical Systems, Inc. | 2007-11-20 |
| NEUROVISION JJB SYSTEM (K072343) | Nuvasive, Inc. | 2007-10-29 |
| BIS MODULE FOR ENVOY PATIENT MONITOR (K071899) | Mennen Medical , Ltd. | 2007-10-22 |
| CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 (K071931) | Codman & Shurtleff, Inc. | 2007-10-22 |
| CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE (K072016) | Technomed Europe | 2007-10-19 |
| VECTOR VISION HIP (K072716) | Brainlab AG | 2007-10-12 |
| VECTORVISION HIP AND HIP SR (K072573) | Brainlab AG | 2007-10-11 |
| WIDE SPACED QUATTRODE LEADS (K072462) | Advanced Neuromodulation Systems | 2007-10-11 |
| MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC (K072173) | Micrus Endovascular Corporation | 2007-10-05 |
| VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER) (K071962) | Cordis Neurovascular, Inc. | 2007-09-26 |
| BRAINSUITE NET (K070556) | Brainlab AG | 2007-09-25 |
| NEURO WAVE 6 (K062003) | Lhasa Oms, Inc. | 2007-09-19 |
| NAVITRACK SYSTEM- PARTIAL HIP RESURFACING UNIVERSAL (K071929) | Orthosoft, Inc. | 2007-09-19 |
| EYETRACKER/IDEAS (K070670) | S.A. Instrumentation Difra | 2007-09-18 |
| MIDAS REX CURVED BUR (K072315) | Medtronic Powered Surgical Solutions | 2007-09-18 |
| BRM3 BRAIN MONITOR (K071449) | Brainz Instruments , Ltd. | 2007-09-14 |
| RT300-S, RT300-SP (PEDIATRIC VERSION), MODEL FA100052, FA100053 (K071486) | Restorative Therapies, Inc. | 2007-09-10 |
| CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS) (K070694) | Mike Miner | 2007-09-10 |