| ALLURA 3D-CA, RELEASE 1 (K042334) | Philips Medical Systems North America Co. | 2004-09-27 |
| UBIPACS (K042507) | Icm Co., Ltd. | 2004-09-27 |
| PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER (K041914) | Kendall | 2004-09-27 |
| KODAK COLOR MEDICAL IMAGER 1000 (K042159) | Eastman Kodak Company | 2004-09-24 |
| TEH LIN POWER SCOOTER, MODEL TL-822 (K042012) | Teh Lin Prosthetic & Orthopaedic, Inc. | 2004-09-24 |
| FIDIS CELIAC (K041002) | Biomedical Diagnostics S.A. | 2004-09-24 |
| LEONARDO SYNGO CARDIOLOGY WORKSTATION (K042203) | Siemens Medical Solutions USA, Inc. | 2004-09-24 |
| CERVICAL PLATE (K042317) | Scient'X | 2004-09-24 |
| PS MEDICAL NEUROSURGICAL IMPLANTS (K042198) | Medtronic Neurosurgery | 2004-09-24 |
| ST360 SPINAL FIXATION SYSTEM (K041925) | Zimmer Spine, Inc. | 2004-09-24 |
| MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL (K042342) | Usa Instruments, Inc. | 2004-09-24 |
| LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM (K041349) | Ibl GmbH | 2004-09-24 |
| JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE (K042312) | Smith & Nephew, Inc. | 2004-09-24 |
| QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE (K042442) | Orion Diagnostica, OY | 2004-09-24 |
| MODIFIED SPACEMAKER SYSTEM (K042412) | United States Surgical, A Division of Tyco Healthc | 2004-09-24 |
| HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM (K042019) | Howmedica Osteonics Corp. | 2004-09-24 |
| POWER SCOOTER, MODEL TL0821 (K042011) | Teh Lin Prosthetic & Orthopaedic, Inc. | 2004-09-24 |
| PERSONAL LUBRICATING GEL (K041129) | Qualis, Inc. | 2004-09-24 |
| INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED (K041837) | Innolatex Sdn. Bhd | 2004-09-24 |
| KODAK MEDICAL IMAGER 300 (K042158) | Eastman Kodak Company | 2004-09-24 |
| FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211 (K041792) | Fresenius Medical Care North America | 2004-09-24 |
| STOCKERT SCP RHYTHM (K042374) | Stockert Instrumente GmbH | 2004-09-23 |
| DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER (K042016) | Datascope Corp. | 2004-09-23 |
| SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS (K041591) | Howmedica Osteonics Corp. | 2004-09-23 |
| IMPLANTEO IMPLANTOLOGY MOTOR (K041279) | Anthogyr | 2004-09-23 |
| D-VAPOR (K042276) | Draeger Medical, Inc. | 2004-09-23 |
| Lysus Infusion System (K042456) | Ekos Corp. | 2004-09-23 |
| MODIFICATION TO: REPROCESSED OXIMAX PULSE OXIMETER SENSORS (K041127) | Sterilmed, Inc. | 2004-09-23 |
| MODIFICATION TO VBR SPINAL SYSTEM (K041722) | Depuy Spine, Inc. | 2004-09-23 |
| VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP) (K041909) | Vascular Solutions, Inc. | 2004-09-23 |
| CLIPPER DIAGNOSTIC ELECTRODE CATHETER (K042105) | Bard Electrophysiology | 2004-09-23 |
| MAGNITUDE 3150M MRI PATIENT MONITOR, MODEL 3150M (K040915) | Invivo Research, Inc. | 2004-09-22 |
| MHLX7EC TRANSDUCER (K040213) | Microhelix, Inc. | 2004-09-22 |
| AMBU DISPOSABLE ECG ELECTRODE (K041734) | Ambu, Inc. | 2004-09-22 |
| SMARTINFUSER PAINPUMP (K042122) | Precise Medical Products | 2004-09-22 |
| CLARISSA INFANT NCPAP CANNULA (K032922) | Airways Ltd., Inc. | 2004-09-22 |
| TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN) (K042426) | Taiject Medical Device Co., Ltd. | 2004-09-22 |
| IPLAN! FLOW (K041330) | Brainlab AG | 2004-09-22 |
| MANTRA ELECTRODE (K041902) | Mantra Intl. (Hk) , Ltd. | 2004-09-22 |
| HOLTER PLUS (K042463) | Rozinn Electronics, Inc. | 2004-09-22 |
| CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12 (K041890) | Cryocor, Inc. | 2004-09-22 |
| NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L (K041779) | Nipro Medical Corp. | 2004-09-21 |
| RADIOPAQUE, GLASS IONOMER ENDODONTIC CEMENT (K042215) | Premier Dental Products Co. | 2004-09-21 |
| MODIFICATION TO: CRESCO TI IMPLANT CONCEPT (K042354) | Cresco TI Systems AB | 2004-09-21 |
| ULTRASOUND CAPTURE SYSTEM (K042042) | Heartlab, Inc. | 2004-09-21 |
| MICROSCOPE SYSTEM (K041805) | Miras Mirror Imaging Solutions, Ltd. | 2004-09-21 |
| ARTELON SPACER CMC-1 (K040070) | Artimplant AB | 2004-09-21 |
| AMERICAN DENTAL IMPLANT (K042462) | American Dental Implant Corporation | 2004-09-21 |
| CAVERMAP SURGICAL AID (K041732) | Blue Torch Medical Technologies | 2004-09-21 |
| LNCS OXIMETRY SENSORS (K042346) | Masimo Corporation | 2004-09-20 |
| VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS (K041863) | Ortho-Clinical Diagnostics, Inc. | 2004-09-20 |
| MACROPORE PURICEL LIPOPLASTY SYSTEM (K042261) | Macropore Biosurgery, Inc. | 2004-09-20 |
| CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S (K042142) | Chad Therapeutics, Inc. | 2004-09-20 |
| NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE (K042378) | Shijiazhuang Tillotson Rubber Products Co., Ltd. | 2004-09-20 |
| ZEWA MFM-007 BLOOD PRESSURE MONITOR (K041491) | Zewa, Inc. | 2004-09-20 |
| BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR (K042100) | Blackstone Medical, Inc. | 2004-09-20 |
| BONE FUSION PLATE SYSTEM (K042205) | Wrightmedicaltechnologyinc | 2004-09-20 |
| ULTRACLIP II US (K042341) | Inrad | 2004-09-20 |
| BIOMARC PRELOADED TISSUE MARKER DEVICE (K042296) | Carbon Medical Technologies, Inc. | 2004-09-20 |
| SILVERSITE OR CALGITROL (K041268) | Adri | 2004-09-20 |
| FEATHERLIFT EXTENDED LENGTH APTOS THREAD (K041593) | Surgical Specialties Corp | 2004-09-20 |
| IRIS MEDICAL IQ 810 PHOTOCOAGULATOR (K040209) | Iridex Corp | 2004-09-20 |
| KUNG SHIN, HMEF SK203 (K032878) | Kung Shin Plastics Co., Ltd. | 2004-09-20 |
| GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM (K041524) | Datex-Ohmeda, Inc. | 2004-09-20 |
| EZ HUBER SAFETY INFUSION SET (K040533) | Pfm Medical, Inc. | 2004-09-17 |
| XPLORER 1600 (K042041) | Imaging Dynamics Company Limited | 2004-09-17 |
| NARCOTREND, MODEL COMPACT 4.0 (K033543) | Mt Monitortechnik GmbH & Co. KG | 2004-09-17 |
| BD FACSCANTO WITH BD FACSANTO SOFTWARE (K041074) | Bd Biosciences | 2004-09-17 |
| SCEPTREP3 PET/CT (K042428) | Hitachi Medical Systems America, Inc. | 2004-09-17 |
| ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05 (K042335) | Bio-Rad Laboratories, Inc. | 2004-09-17 |
| BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM (K042251) | Bayer Healthcare, LLC | 2004-09-17 |
| ORION ANTERIOR CERVICAL PLATING SYSTEM (K042235) | Medtronic Sofamor Danek | 2004-09-17 |
| ORTHOFIBER (K041894) | Cp Medical | 2004-09-17 |
| CRONO F (K042085) | Cane S.R.L. | 2004-09-17 |
| ROBOCOUCH PATIENT SUPPORT SYSTEM (K042146) | Accuray Incorporated | 2004-09-17 |
| READY-HEAT BLANKET (K042145) | Techtrade, LLC | 2004-09-17 |
| HYPROCURE SUBTALAR IMPLANT SYSTEM (K042030) | Graham Medical Technologies, LLC | 2004-09-16 |
| THE PRODIGY SYSTEM DENTAL IMPLANTS (K042429) | BioHorizons Implant Systems, Inc. | 2004-09-16 |
| BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE (K042244) | Triage Medical, Inc. | 2004-09-16 |
| SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020 (K042295) | Linvatec Biomaterials, Ltd. | 2004-09-16 |
| RF INTRODUCTION CANNULA (K041021) | Epimed International, Inc. | 2004-09-16 |
| LSC LIFESTAND COMPACT (K041535) | Lifestand | 2004-09-16 |
| CALLOS CMF BONE VOID FILLER (K042072) | Skeletal Kinetics, LLC | 2004-09-16 |
| EBI PERIARTICULAR PLATING SYSTEM (K042237) | Ebi, L.P. | 2004-09-16 |
| DUET SYSTEM (K040591) | Bioview , Ltd. | 2004-09-16 |
| SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747 (K042195) | Beckman Coulter, Inc. | 2004-09-16 |
| COMPRESSION ANASTOMOSIS CLIP (CAC) (K041751) | Niti Medical Technologies , Ltd. | 2004-09-16 |
| ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER (K042326) | Ultrasonix Medical Corporation | 2004-09-16 |
| CORAL SPINAL SYSTEM (K041592) | Theken Surgical | 2004-09-16 |
| MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY (K042281) | Beckman Coulter, Inc. | 2004-09-16 |
| ACON AMP 300 ONE STEP AMPHETAMINE TEST STRIP AND DEVICE (K041822) | ACON Laboratories, Inc. | 2004-09-16 |
| MEDCOMP T-3 (K033570) | Medcomp | 2004-09-16 |
| RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES (K040377) | Radiant Innovation, Inc. | 2004-09-16 |
| PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A (K040904) | Philips Medical Systems | 2004-09-16 |
| SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X (K041989) | Sintea Biotech, Inc. | 2004-09-16 |
| CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE (K042338) | Lake Region Mfg., Inc. | 2004-09-16 |
| XLTEK CONNEX IP HEADBOX, MODEL 1054 (K042223) | Excel Tech. , Ltd. | 2004-09-16 |
| ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS (K033599) | The Lagado Corp. | 2004-09-16 |
| CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (K042238) | Seal Polymer Industries Bhd. | 2004-09-16 |
| ORTHO-PRO CANNULATED BONE SCREWS (K042310) | Ortho-Pro, LLC | 2004-09-16 |