| NIO FUSION 4MP; MDNC 4130 (K062905) | Barcoview | 2006-12-29 |
| ELIA CELIKEY IGA WELL, MODEL 14-5517-01; ELIA CELIAC CONTROL, MODEL 83-1011-01 (K062787) | Phadia US, Inc. | 2006-12-29 |
| MODIFICATION TO HEALTH BUDDY APPLIANCE (K063612) | Health Hero Network, Inc. | 2006-12-29 |
| RAINBOW ADHESIVE CO-OXIMETRY SENSORS (K063140) | Masimo Corporation | 2006-12-29 |
| VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV (K063164) | Ortho-Clinical Diagnostics, Inc. | 2006-12-28 |
| DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX (K053218) | Musculoskeletal Transplant Foundation | 2006-12-28 |
| INNERSCAN BODY COMPOSITION MONITOR, INNERSCAN SEGMENTAL BODY COMPOSITION MONITOR (K062652) | Tanita Corporation of America | 2006-12-28 |
| CLINITEK ADVANTUS, MODEL 1420 (K063276) | Bayer Healthcare, LLC | 2006-12-28 |
| COLLIMATOR, MODEL M-38 (K062788) | Umi International | 2006-12-28 |
| DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH (K063206) | Dade Behring, Inc. | 2006-12-28 |
| EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G (K062555) | Visgeneer, Inc. | 2006-12-27 |
| MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM (K063643) | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2006-12-27 |
| ENA CEM (K062355) | Micerium S.P.A. | 2006-12-27 |
| CANDELA 3630 LASER SYSTEM (K063074) | Candela Corp. | 2006-12-27 |
| METAIZEAU NAILING SYSTEM (K063225) | Howmedica Osteonics Corp. | 2006-12-27 |
| ARC SURGICAL BONE REDUCTION SCREW (K063244) | Arc Surgical, LLC | 2006-12-27 |
| AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM (K063017) | Aesculap, Inc. | 2006-12-27 |
| CARBON DIOXIDE MONITOR, MODEL OLG-2800A (K062115) | Nihon Kohden America, Inc. | 2006-12-27 |
| FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES) (K063009) | Praesidia S.R.L. | 2006-12-27 |
| RIGIDOMETER, MODEL DIR-4U (K061676) | Uroan 21 | 2006-12-27 |
| AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS (K063262) | Virtual Imaging | 2006-12-26 |
| CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY (K063628) | Ge Healthcare Integrated IT Solutions | 2006-12-26 |
| CRANEX NOVUS (K063459) | Soredex Palodex Group OY | 2006-12-26 |
| OBELISC VERTEBRAL BODY REPLACEMENT DEVICE (K060416) | Ulrich GmbH & Co. KG | 2006-12-26 |
| ELIA CELIKEY IGG WELL, MODEL 14-5518-01, ELIA CELIAC CONTROL, MODEL 83-1011-01 (K062583) | Phadia US, Inc. | 2006-12-26 |
| STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK (K062924) | Dade Behring, Inc. | 2006-12-26 |
| SSP VERTEBRAL BODY REPLACEMENT (K061578) | Specialty Spine Products, LLC | 2006-12-26 |
| MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE (K063613) | Terumo Medical Corp. | 2006-12-26 |
| MOONCUP (K060852) | Mooncup Limited | 2006-12-26 |
| LTD POLYAXIAL FIXATION SYSTEM (K062785) | Us Spine | 2006-12-26 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS RUBELLA IGG REAGANT PACK AND CALIBRATORS (K063143) | Ortho-Clinical Diagnostics, Inc. | 2006-12-26 |
| HDR CT COMPATIBLE SPLIT RING APPLICATOR (K063382) | Mick Radio-Nuclear Instruments, Inc. | 2006-12-26 |
| CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM (K062265) | Swiss Medical Care S.A. | 2006-12-26 |
| HORUS LASER KERATOME (K062314) | Carl Zeiss Meditec, AG | 2006-12-22 |
| AEQUALIS RESURFACING HEAD (K062661) | Tornier | 2006-12-22 |
| AEQUALIS HUMERAL PLATE (K063551) | Tornier | 2006-12-22 |
| COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 (K063543) | Roche Diagnostics Corp. | 2006-12-22 |
| ELECTRIC POWERED WHEELCHAIR MODEL-MINI (P14) (K063474) | Imc-Heart Way LLC | 2006-12-22 |
| LITHODIAMOND ULTRA (K061350) | Pck Electronic Industry & Trade Co., Ltd. | 2006-12-22 |
| CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (K062965) | Kossan Latex Industries(M)Sdn Bhd | 2006-12-22 |
| ULTRAZONIX SPINE MINIMAL-INVASIVE DISC SYSTEM (K060346) | Ultrazonix Dnt AB | 2006-12-22 |
| VITROS CHEMISTRY PRODUCTS BENZ REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV (K062285) | Ortho-Clinical Diagnostics, Inc. | 2006-12-22 |
| I.T.S. PELVIC RECONSTRUCTION SYSTEM (K063166) | I.T.S. Implantat-Technologie-Systeme GmbH | 2006-12-22 |
| IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP (K063057) | Diagnostic Products Corporation | 2006-12-22 |
| O&P BIVALVE CRANIAL MOLDING HELMET (K063395) | Orthotic & Prosthetic Lab, Inc. | 2006-12-22 |
| PATIENT DATA HANDLER & DEVICES (PDH&D) (K063484) | Intermed Advisors, Inc. | 2006-12-22 |
| APEX SPINE SYSTEM (K062513) | Spinecraft, Inc. | 2006-12-22 |
| ELECTROSURGICAL HEMOSTATIC FORCEPS SERIES (K062517) | Olympus Medical Systems Corporation | 2006-12-22 |
| BONE INJECTION GUN (B.I.G.) (K062940) | Waismed, Ltd. | 2006-12-22 |
| GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROL (K063224) | Gentris Corporation | 2006-12-22 |
| INTERDRY TEXTILE WITH SILVER (K061615) | Milliken Chemical | 2006-12-22 |
| SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER (K060851) | The Smithworks Company | 2006-12-22 |
| BOX PEEK VBR SYSTEM (K062151) | Innovasis, Inc. | 2006-12-22 |
| HUMERUS LOCKING PLATING SYSTEM (K063095) | Newclip Technics | 2006-12-22 |
| TRAVERSE OCT SPINAL FIXATION SYSTEM (K062879) | Medtronic Sofamor Danek, Inc. | 2006-12-22 |
| BWII EEG DIGITAL, MODEL PV 1652; BWII PSG DIGITAL, MODEL PV 1524 (K062533) | Neurovirtual USA, Inc. | 2006-12-22 |
| OPUS HC482 DIRECT NASAL MASK (K063036) | Fisher & Paykel Healthcare, Ltd. | 2006-12-22 |
| QUANTA LITE INTRINSIC FACTOR ELISA (K061841) | Inova Diagnostics, Inc. | 2006-12-22 |
| SUBDERMAL WIRE ELECTRODE, MODEL SWE (K062880) | Ives Eeg Solutions, Inc. | 2006-12-22 |
| LIFEPAK 20 DEFIBRILLATOR/ MONITOR (K063119) | Medtronic Emergency Response Systems, Inc. | 2006-12-22 |
| ALLERGEAZE PATCH TEST CHAMBERS (K063160) | Smartpractice | 2006-12-22 |
| ENTEROCOCCUS FAECALIS PNA FISH (K063127) | Advandx, Inc. | 2006-12-22 |
| CT COMPATIBLE F/S/D APPLICATORS (K063381) | Mick Radio-Nuclear Instruments, Inc. | 2006-12-22 |
| INTEGRA RADIONICS IMAGEFUSION 3 (K063230) | Integra Radionics, Inc. | 2006-12-21 |
| FILM DIGITZER, MODEL 2908 MAMMO PRO (K063424) | Array Corp. | 2006-12-21 |
| I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0 (K063493) | Boston Scientific Corp | 2006-12-21 |
| VS-800 VITAL SIGNS MONITOR (K063055) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006-12-21 |
| CALYSTO SERIES IV PHYSIO-MONITORING AND INFORMATION SYSTEM (K063547) | Witt Biomedical Corp | 2006-12-21 |
| HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER (K063518) | Hitachi Medical Systems America, Inc. | 2006-12-21 |
| AUTOPULSE RESUSCITATION SYSTEM MODEL100 (K063602) | Zoll Circulation | 2006-12-21 |
| UNISYN HA PLASMA MODULAR HIP (K062383) | Hayes Medical, Inc. | 2006-12-21 |
| POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE) (K062950) | Hartalega Sdn Bhd | 2006-12-21 |
| VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE (K063492) | bioMerieux, Inc. | 2006-12-21 |
| ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX (K063182) | Enpath Medical, Inc. | 2006-12-21 |
| CITRIC ACID 20% SOLUTION, MODEL 329 (K063703) | Ultradent Products, Inc. | 2006-12-21 |
| DPILOG, MODEL DPC-512 (K062811) | Life Outcomes, Inc. | 2006-12-20 |
| BIOGEL ECLIPSE INDICATOR UNDERGLOVE (K062847) | Molnlycke Health Care Us, LLC | 2006-12-20 |
| TRIDENT II ACETABULAR SYSTEM (K063616) | Howmedica Osteonics Corp. | 2006-12-20 |
| MOZAIK BONE REGENERATION MATRIX - PUTTY (K062353) | Integra LifeSciences Corporation | 2006-12-20 |
| AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 (K063015) | Ameditech, Inc. | 2006-12-20 |
| SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC AND SUSCEPTIBILITY PLATES (K062841) | Trek Diagnostic Systems, Inc. | 2006-12-20 |
| FLIPPER DETACHABLE EMBOLIZATION COILS (K063619) | Cook, Inc. | 2006-12-20 |
| ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE (K062277) | Atlantis Components, Inc. | 2006-12-20 |
| FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 (K063068) | Arkray USA, Inc. | 2006-12-20 |
| HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER (K061227) | The Hymed Group Corp. | 2006-12-20 |
| CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS (K063073) | Candela Corp. | 2006-12-20 |
| CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES (K063072) | Candela Corp. | 2006-12-20 |
| XCEL 255 SLIT LAMP (K063750) | Reichert, Inc. | 2006-12-20 |
| MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05 (K061461) | Zimmer, Inc. | 2006-12-20 |
| CORTISOL ELISA (K062626) | Ibl-Hamburg GmbH | 2006-12-20 |
| MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM (K063497) | Scandius Biomedical, Inc. | 2006-12-19 |
| NEEDLELESS SLING (K063136) | Specialities Remeex International, S.L. | 2006-12-19 |
| CITADEL ANTERIOR LUMBAR PLATE SYSTEM (K062836) | Globus Medical, Inc. | 2006-12-19 |
| RUIKE, MODEL 3431 (K062645) | Shanghai Ruike Sports Goods Co., Ltd. | 2006-12-19 |
| BAUSCH & LOMB NGX MICROSURGICAL SYSTEM (K063331) | Bausch & Lomb, Inc. | 2006-12-19 |
| VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303 (K062838) | Ortho-Clinical Diagnostics | 2006-12-19 |
| MODEL 2200 (K062635) | Clarimedex, Inc. | 2006-12-19 |
| REST ASSURED NITE PROTECTOR (K063229) | Ranir, LLC | 2006-12-19 |
| X-STEN MILD TOOL KIT, MODEL MTK-0001 (K062038) | X-Sten Corp. | 2006-12-19 |
| NOBELPERFECT CONICAL CONNECTION (K062936) | Nobel Biocare AB | 2006-12-19 |