| PASCO MIC AND MIC/ID PANELS (K041776) | Pasco Laboratories, Inc. | 2004-08-03 |
| BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML (K041970) | Biotop Technology Co., Ltd. | 2004-08-03 |
| VERSAWAVE DENTAL ER:YAG LASER SYSTEM (K041710) | Hoya Conbio | 2004-08-03 |
| PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES (K033730) | Pmt Corp. | 2004-08-03 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE (K041384) | Becton, Dickinson & CO | 2004-08-03 |
| NEUROGUIDE ANALYSIS SYSTEM (K041263) | Applied Neuroscience, Inc. | 2004-08-03 |
| PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K041796) | Cordis Corporation | 2004-08-03 |
| PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP (K041806) | Depuy Mitek, A Johnson & Johnson Company | 2004-08-03 |
| ASAHI PTCA GUIDE WIRE CONFIANZA PRO (K041531) | Asahi Intecc Co., Ltd. | 2004-08-03 |
| ALLOMATRIX PUTTY (K041168) | Wrightmedicaltechnologyinc | 2004-08-02 |
| CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996 (K041173) | Sweden Diagnostics (Germany) GmbH | 2004-08-02 |
| MARPAC MESSENGER MODEL #501 (K041485) | Marpac, Inc. | 2004-08-02 |
| VARELISA GLIADIN IGG ANTIBODIES (K041357) | Sweden Diagnostics (Germany) GmbH | 2004-08-02 |
| BIO 60 (K041378) | Kodent, Inc. | 2004-08-02 |
| OLYMPUS STERILIZATION TRAYS (K033222) | Olympus Winter & Ibe GmbH | 2004-08-02 |
| COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM (K041352) | Biomet, Inc. | 2004-07-30 |
| UNDECIDED (K041484) | Siemens Medical Solutions USA, Inc. | 2004-07-30 |
| CERCON CERAM EXPRESS CERAMIC SYSTEM (K041707) | Dentsply Intl. | 2004-07-30 |
| ANTERIOR COMPACT SYSTEM (K041469) | X-Spine Systems | 2004-07-30 |
| M'ATH STD (K040686) | Intelligence IN Medical Technologies | 2004-07-30 |
| 55CM POURCHEZ RETRO SAFE TRAC TWIN LUMEN HEMODIALYSIS CATHETER MODEL #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 (K041559) | Spire Biomedical, Inc. | 2004-07-30 |
| CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR (K041700) | Cantor & Nissel , Ltd. | 2004-07-30 |
| SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR (K033655) | Soflex Contact Lens Industries , Ltd. | 2004-07-30 |
| ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM (K041916) | Aloka Co. Ltd USA | 2004-07-30 |
| ALLURA XPER FD10 (K041949) | Philips Medical Systems North America Co. | 2004-07-30 |
| APEX MEDICAL CPAP MODEL 9S-003 (K041828) | Apex Medical Corp. | 2004-07-30 |
| THERA-CREAM, MODEL TCT004 (K032239) | Prizm Medical, Inc. | 2004-07-30 |
| MODIFICATION TO SMALL BONE FIXATION SYSTEM (K041157) | Hand Innovations, Inc. | 2004-07-30 |
| HUMERAL STAPLE (K041355) | Smith & Nephew, Inc. | 2004-07-30 |
| NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES (K031858) | Richard Wolf Medical Instruments Corp. | 2004-07-29 |
| FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE) (K041644) | Elekon Industries U.S.A., Inc. | 2004-07-29 |
| MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215 (K033614) | Northgate Technologies, Inc. | 2004-07-29 |
| LNCS OXIMETRY SENSORS (K041815) | Masimo Corp. | 2004-07-29 |
| DENTIUM CO., LTD. IMPLANTIUM (K041368) | Dentium Co., Ltd. | 2004-07-29 |
| GEMINI PET/CT IMAGING SYSTEM (K041955) | Philips Medical Systems (Cleveland), Inc. | 2004-07-29 |
| MERLIN E-MASK (K031397) | Merlin Medical Limited | 2004-07-29 |
| 15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706 (K040992) | Medcomp | 2004-07-29 |
| MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E (K041223) | Maquet Critical Care AB | 2004-07-29 |
| SUTURE ARROW (K041128) | Linvatec Corp. | 2004-07-29 |
| PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C (K041664) | On Site Gas Systems, Inc. | 2004-07-29 |
| CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET (K041044) | Cook, Inc. | 2004-07-29 |
| SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE (K040682) | Grand Work Plastic Products Co., Ltd. | 2004-07-28 |
| EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE (K033463) | Edwards Lifesciences, LLC | 2004-07-28 |
| ARTHROJET XT (K041233) | Hydrocision, Inc. | 2004-07-28 |
| RESORBABLE INTERFERENCE SCREW (K041274) | Arthrotek, Inc. | 2004-07-28 |
| MACROPORE HYDROSORB SPINE SYSTEM (K041105) | Macropore Biosurgery, Inc. | 2004-07-28 |
| CERAGEM-C THERMAL ACUPRESSURE MASSAGER (K040031) | Ceragem Co., Ltd. | 2004-07-28 |
| DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES (K041772) | Datex-Ohmeda | 2004-07-28 |
| HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE (K041399) | Smiths Medical Asd, Inc. | 2004-07-28 |
| PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 (K041410) | Icu Medical, Inc. | 2004-07-28 |
| GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR (K041922) | General Electric Co. | 2004-07-28 |
| CEDIA SIROLIMUS ASSAY (DEN040008) | Microgenics Corp. | 2004-07-28 |
| KAPP CUSTOM ULNAR HEAD WRIST IMPLANT (K033930) | Kapp Surgical Instrument, Inc. | 2004-07-28 |
| QUATRO M FEMORAL COMPONENT (K033313) | Whiteside Biomechanics, Inc. | 2004-07-28 |
| PILLAR PALATAL IMPLANT SYSTEM (K040417) | Restore Medical, Inc. | 2004-07-28 |
| GUIDANT MICROWAVE ABLATION SYSTEM (K041340) | Guidant Corporation, Cardiac Surgery | 2004-07-28 |
| MEDCOMMONS OPEN RADIOLOGY GATEWAY (K041326) | Medcommons, Inc. | 2004-07-27 |
| ORTHO-CMS (K041162) | Medis Medical Imaging Systems BV | 2004-07-27 |
| COBRA ADHERE SURGICAL SYSTEM (K041599) | Estech, Inc. | 2004-07-27 |
| MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC) (K041812) | Roche Diagnostics Corp. | 2004-07-27 |
| AOC BONE WAX (K041363) | Ceremed , Inc. | 2004-07-27 |
| CAAS MRV (K041682) | Pie Medical Imaging BV | 2004-07-27 |
| N APOLIPOPROTEIN STANDARD SERUM (K041870) | Dade Behring, Inc. | 2004-07-27 |
| DUREPAIR DURA REGENERATION MATRIX (K041000) | Medtronic Neurosurgery | 2004-07-27 |
| ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING (K040560) | Ab Biodisk | 2004-07-27 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND SUSCEPTIBILITY TEST PANEL (K041534) | Trek Diagnostic Systems, Ltd. | 2004-07-27 |
| QWIKCHECK-BEADS (K041600) | Medical Electronics Systems , Ltd. | 2004-07-27 |
| REPROCESSED SURGICAL SCISSORS AND GRASPERS (K033592) | Clearmedical, Inc. | 2004-07-27 |
| JMS ABSORBABLE ANCHOR AND APPLICATOR (K041159) | Jms, Inc. | 2004-07-27 |
| ACNELIFT (K041103) | Inner Act, LLC | 2004-07-27 |
| SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR (K041328) | Smith & Nephew, Inc. | 2004-07-27 |
| CYTO-CHEX BCT (K040107) | Streck Laboratories, Inc. | 2004-07-27 |
| PANORAMA 1.0T (K041602) | Philips Medical Systems North America, Inc. | 2004-07-26 |
| ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT (K041420) | AngioDynamics, Inc. | 2004-07-26 |
| GE SIGNA PROFILE 6 INCH GP COIL (K041921) | Ge Medical Systems, LLC | 2004-07-26 |
| ECLIPSE WITH AAA (K041403) | Varian Medical Systems | 2004-07-26 |
| PERIOLASE ND:YAG DENTAL LASER SYSTEM (K030290) | Millennium Dental Technologies, Inc. | 2004-07-26 |
| AMERICAN BANTEX MS 4 MINI SCOOTER (K040754) | American Bantex Corp. | 2004-07-23 |
| SINON SN-L402 LIGHTWEIGHT WHEELCHAIR (K041465) | Sinon Corporation | 2004-07-23 |
| NORIAN SRS FAST SET PUTTY (K041842) | Synthes (Usa) | 2004-07-23 |
| DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE (K041790) | Datex-Ohmeda | 2004-07-23 |
| HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX (K041726) | Asahi Medical Co., Ltd. | 2004-07-23 |
| EQUESTRA FLUID DELIVERY SYSTEM (K040483) | Medtronic Sofamor Danek, Inc. | 2004-07-23 |
| STRAUMANN TEMPORARY COPING (K041070) | The Straumann Co. | 2004-07-23 |
| LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS (K041138) | CooperVision, Inc. | 2004-07-23 |
| L1-PRO SYSTEM (K041665) | Pelikan Technologies, Inc. | 2004-07-23 |
| TRIO MONITOR (K041907) | Datascope Corp. | 2004-07-23 |
| SILVERSEAL (K040019) | Noble Fiber Technologies | 2004-07-23 |
| MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 (K041727) | Boston Scientific Scimed, Inc. | 2004-07-23 |
| PTS PANELS CHOL+GLU TEST PANEL (K041750) | Polymer Technology Systems, Inc. | 2004-07-23 |
| LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM (K040844) | Life Spine, LLC | 2004-07-23 |
| M2376A DEVICELINK SYSTEM (K041942) | Phillips Medical Systems | 2004-07-23 |
| NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) (K040913) | Bausch & Lomb | 2004-07-23 |
| EXTENTRAC ELITE (K031996) | Advanced Back Technologies | 2004-07-23 |
| LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE (K041695) | Usa Instruments, Inc. | 2004-07-23 |
| PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS (K041675) | Pie Medical | 2004-07-23 |
| KARMA POWER WHEELCHAIR, MODEL KP-25 (K041678) | Karma Medical Products Co., Ltd. | 2004-07-23 |
| ELEKTA MICRODRIVE, MODEL 916716 (K040979) | Elekta Instrument AB | 2004-07-23 |
| TRIMED PLAN, VERSION 2.2 (K031088) | Trimed Systems, Inc. | 2004-07-23 |
| XPS 3000 SYSTEM (K041523) | Medtronic Xomed, Inc. | 2004-07-23 |