| FISCH TITANIUM MIDDLE EAR PROSTHESES (K043375) | Karl Storz Endoscopy | 2005-01-24 |
| INTEGRITY, MODEL V500 (K043396) | Vivosonic, Inc. | 2005-01-24 |
| ARCHITECT STAT MYO IMMUNOASSAY (K042924) | Fisher Diagnostics | 2005-01-24 |
| MODIFICATION TO OUTBACK CATHETER (K043534) | Lumend, Inc. | 2005-01-21 |
| PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359 (K043560) | Zimmer, Inc. | 2005-01-21 |
| LAPEX 2000 (K034009) | Meridian Co., Ltd. | 2005-01-21 |
| R2-MRI ANALYSIS SYSTEM (K043271) | Inner Vision Biometrics Pty, Ltd. | 2005-01-21 |
| INFINITY PLUS ELECTROTHERAPY SYSTEM (K041920) | Empi | 2005-01-21 |
| TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE (K043113) | DePuy Orthopaedics, Inc. | 2005-01-21 |
| PROCEDUR 10 SYRINGE DEVICE (K042486) | Avanca Medical Devices, Inc. | 2005-01-21 |
| OCT-OPTHALMOSCOPE (K042885) | Ophthalmic Technologies, Inc. | 2005-01-21 |
| INFINITY GATEWAY SUITE, VF4 (K043549) | Draeger Medical Systems, Inc. | 2005-01-21 |
| ALLOGRAN-N-BONE VOID FILLER (K043514) | Biocomposites, Ltd. | 2005-01-21 |
| OPTISTRAND, MODEL 1032S (K043336) | Ibt SA | 2005-01-21 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML (K043389) | Becton, Dickinson & CO | 2005-01-21 |
| PROCEDUR SF SAFETY SYRINGE DEVICE (K042487) | Avanca Medical Devices, Inc. | 2005-01-21 |
| MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS (K042774) | Biomet, Inc. | 2005-01-21 |
| AIRSTRIP OB (K042082) | Mp4 Solutions, LP | 2005-01-21 |
| MULTI-USE COMPRESSION SCREW (K043102) | Wrightmedicaltechnologyinc | 2005-01-21 |
| PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER) (K043206) | Pioneer Surgical Technology | 2005-01-21 |
| CENTRICITY PACS SYSTEM (K043415) | Ge Medical Systems Information Technologies | 2005-01-21 |
| CEREBRAL STATE MONITOR - CSM (K042315) | Danmeter A/S | 2005-01-21 |
| OCEAN CHEST DRAIN (K043582) | Atrium Medical Corp. | 2005-01-21 |
| MODIFICATION TO: RADIANALYZER, MODEL 12711 (K042628) | Radi Medical Systems AB | 2005-01-19 |
| DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) (K043508) | Ansell Healthcare Products, LLC | 2005-01-19 |
| FLOWCARE PLG CD4 REAGENT (K043215) | Beckman Coulter, Inc. | 2005-01-19 |
| TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840 (K043382) | Tiara Medical Systems, Inc. | 2005-01-19 |
| SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000 (K042961) | Novadaq Technologies, Inc. | 2005-01-19 |
| PINN-ACL CROSSPIN (K043106) | Linvatec Corp. | 2005-01-19 |
| LIFESCREEN APNEA (K042745) | Del Mar Reynolds Medical, Inc. | 2005-01-19 |
| VISTA PLUS (K042108) | Novacor | 2005-01-19 |
| CHARLOTTE HIGH-DEMAND COMPRESSION SCREW (K043281) | Wrightmedicaltechnologyinc | 2005-01-19 |
| OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400 (K043060) | Omron Healthcare, Inc. | 2005-01-19 |
| MASIMO SET RAD 57 PULSE CO-OXIMETER (K042536) | Masimo Corporation | 2005-01-19 |
| DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE (K043546) | Dade Behring, Inc. | 2005-01-18 |
| DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER (K042709) | Tyco Healthcare | 2005-01-18 |
| PANTHERA N POWDER FREE BLACK NITRILE GLOVES (K042898) | Glovco (M) Sdn. Bhd. | 2005-01-18 |
| COMPRESSION STAPLE AND SIMPLE STAPLE (K043059) | Wrightmedicaltechnologyinc | 2005-01-18 |
| SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE (K043039) | Synthes (Usa) | 2005-01-18 |
| SOUNDSKIN PHOTOTHERAPY SYSTEM (K040103) | Bhc International, Ltd. | 2005-01-18 |
| ATAD ARD CATHETER (K040625) | Atad Developments , Ltd. | 2005-01-18 |
| MEDIN TECH ZIRCONIA-CP10, SS1000 (K043472) | Medin Tech | 2005-01-18 |
| NAVITRACK SYSTEM - S&N IMAGE FREE KNEE (K043536) | Orthosoft, Inc. | 2005-01-14 |
| CABLING SYSTEM TROCHANTER HOOK (K043252) | Smith & Nephew, Inc. | 2005-01-14 |
| TRIMED OSTEOTOMY PLATE (K043263) | TriMed, Inc. | 2005-01-14 |
| DEVILBISS NASAL CPAP MASK, 9354 SERIES (K042455) | Sunrise Medical | 2005-01-14 |
| Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 (K043304) | Bioject Medical Technologies, Inc. | 2005-01-14 |
| TITAN DENTAL IMPLANT SYSTEM (K042971) | Titan Implants, Inc. | 2005-01-14 |
| X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING (K033900) | Noble Fiber Technologies | 2005-01-14 |
| ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 (K043554) | B-K Medical A/S | 2005-01-14 |
| TAPERLOC 12/14 TAPER FEMORAL COMPONENTS (K043537) | Biomet, Inc. | 2005-01-14 |
| THERMAGE THERMACOOL SYSTEM (K043402) | Thermage, Inc. | 2005-01-14 |
| ISSYS PEDICLE SCREW SYSTEM (K043522) | Custom Spine, Inc. | 2005-01-14 |
| 6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC (K043502) | C.R. Bard, Inc. | 2005-01-14 |
| CONCORD Radiopaque Bone Cement (K042168) | Globus Medical, Inc. | 2005-01-14 |
| SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM (K050034) | Siemens Medical Solutions USA, Inc. | 2005-01-13 |
| MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS (K043557) | Panoramic Corp. | 2005-01-13 |
| SAN-MAR LABS LUBRICATING JELLY (K041667) | San-Mar Laboratories, Inc. | 2005-01-13 |
| ICSI-100 (K043116) | Vitrolife Sweden AB | 2005-01-13 |
| ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 (K043226) | Imtec Corp. | 2005-01-13 |
| MIRAGE, RELEASE 5.5 (K043441) | Segami Corporation | 2005-01-13 |
| PALOMAR STARLUX PULSED LIGHT SYSTEM (K041086) | Palomar Medical Products, Inc. | 2005-01-13 |
| NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES, WITH VANILLA SCENTING (K042879) | Sgmp Co., Ltd. | 2005-01-13 |
| VECTORVISION ACL (K042512) | Brainlab AG | 2005-01-13 |
| POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN E (K042567) | Pt. Medisafe Technologies | 2005-01-13 |
| ALOCLAIR ORAL SPRAY (K042722) | Sinclair Pharmaceuticals, Ltd. | 2005-01-13 |
| ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 (K043524) | B-K Medical A/S | 2005-01-13 |
| CARDIO SPECTRUM DIAGNOSTIC SYSTEM (CSD) (K042849) | Cardiobiomedical Corporation | 2005-01-13 |
| PFA PATCH (K041736) | Peritec Biosciences, LLC | 2005-01-13 |
| MEDICON VIPAIR HIGH SPEED SYSTEM (K042974) | Medicon EG | 2005-01-13 |
| PALOMAR LUX1064 HANDPIECE (K041879) | Palomar Medical Technologies, Inc. | 2005-01-13 |
| LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (K042345) | Mondeal Medical Systems GmbH | 2005-01-13 |
| SPSMEDICAL SPORVIEW PA CULTURE SET (K043135) | Spsmedical Supply Corp. | 2005-01-13 |
| REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING (K042602) | Ge Medical Systems, LLC | 2005-01-13 |
| ANEROID SPHYGMOMANOMETER, MODEL BK2002 (K043286) | Wenzhou Bokang Instrument Co.,Ltd | 2005-01-13 |
| PMP4 SELFCHECK ECG (K042254) | Card Guard Scientific Survival , Ltd. | 2005-01-13 |
| POWERSTICK MALE LATEX CONDOMS (K041717) | A.P.Deauville, LLC | 2005-01-13 |
| RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS (K034026) | Fisher & Paykel Healthcare, Ltd. | 2005-01-12 |
| BRAINET KIT (K043009) | Jordan Neuroscience, Inc. | 2005-01-12 |
| TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT (K042993) | Howmedica Osteonics Corp. | 2005-01-12 |
| MODIFICATION TO XIA SPINAL SYSTEM (K043473) | Stryker Spine | 2005-01-12 |
| SMITH & NEPHEW VIDEOARTHROSCOPE (K043395) | Smith & Nephew, Inc. | 2005-01-12 |
| PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS) (K043129) | Opti-Centre Laboratories | 2005-01-12 |
| DURAGEN II DURAL REGENERATION MATRIX (K043427) | Integra Lifesciences Corp. | 2005-01-12 |
| ODYSSEY (K042861) | Permedics, Inc. | 2005-01-12 |
| FLOWMEDIC, MODEL 220 (K042217) | Flowmedic (Israel), Ltd. | 2005-01-12 |
| FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET (K043437) | Health & Life Co., Ltd. | 2005-01-12 |
| SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) (K043559) | Sonosite,Inc. | 2005-01-12 |
| CYNERGY LASER (K043429) | Cynosure, Inc. | 2005-01-12 |
| ASAHI PTCA GUIDE WIRE, J SHAPE SERIES (K043422) | Asahi Intecc Co., Ltd. | 2005-01-12 |
| WILLI GELLER CREATION II PORCELAIN (K043468) | Jensen Int'L, Inc. | 2005-01-12 |
| SMITH & NEPHEW HYBRID KNEE FEMORAL (K042896) | Smith & Nephew, Inc. | 2005-01-12 |
| GE SIGNA EXCITE MR SURGICAL OPTION (K043262) | GE Healthcare | 2005-01-12 |
| DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (K043563) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005-01-11 |
| ENDO TWINN (K042870) | Endo Twinn B.V. | 2005-01-11 |
| VOXAR 3D PRODUCT FAMILY (K043194) | Voxar Limited | 2005-01-11 |
| INBODY, MODEL 3.0 (K042528) | Biospace Corporation Limited | 2005-01-11 |
| WILLI GELLER CREATION ZI PORCELAIN (K043201) | Jensen Industries, Inc. | 2005-01-11 |
| CZR PRESS LF (K043462) | Noritake Co., Inc. | 2005-01-11 |
| MODIFICATION TO SOAKER CATHETER (K043456) | I-Flow Corp. | 2005-01-11 |