| FACTOR II (PROTHROMBIN) G20210A KIT (K033612) | Roche Diagnostics Corp. | 2003-12-18 |
| BTG SMARTEST GLUCOSE TEST SYSTEM (K032029) | Bt Medical | 2003-12-18 |
| BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S280 (K033220) | Tung Keng Enterprise Co., Ltd. | 2003-12-18 |
| MODIFICATION TO SLIM GLIDING NAIL SYSTEM (K033763) | Plus Orthopedics | 2003-12-18 |
| COMPRESS DISTAL FEMORAL REPLACEMENT (K031804) | Biomet, Inc. | 2003-12-18 |
| REPROCESSED DISPOSABLE CUTTERS, STAPLERS AND APPLIERS (K032973) | Vanguard Medical Concepts, Inc. | 2003-12-18 |
| MODIFICATION TO UNITY NETWORK ID (K033672) | Ge Medical Systems Information Technologies | 2003-12-18 |
| COAPT ENDOTINE CHIN 3.5 DEVICE (K033524) | Coapt Systems, Inc. | 2003-12-18 |
| VISU-LOCK 5MM CLIP APPLIER (K033161) | Gyrx, LLC | 2003-12-18 |
| UB 140 (K033827) | Rivertrail Mobility | 2003-12-18 |
| AMI REPROCESSED MULTIPLE CLIP APPLIERS (K032980) | Vanguard Medical Concepts, Inc. | 2003-12-18 |
| MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE (K033746) | ETHICON, Inc. | 2003-12-18 |
| VASCULAR SOLUTIONS D-STAT 2 DRY HEMOSTATIC BANDAGE (K033709) | Vascular Solutions, Inc. | 2003-12-18 |
| COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2 (K031618) | Comfort Orthopedic Co., Ltd. | 2003-12-18 |
| TANGO, MODELS, BP1 (K031711) | American Bantex Corp. | 2003-12-18 |
| BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S200 (K033240) | Tung Keng Enterprise Co., Ltd. | 2003-12-18 |
| EPW FOLDABLE POWER WHEELCHAIR, EPW-03 (K033206) | Emg Technology Co., Ltd. | 2003-12-18 |
| PHOENIX INFANT RADIANT WARMER, MODEL 100NWS (K033040) | International Hospital Supply Co. | 2003-12-17 |
| (MULTIPLE LABELS) POWDER-FREE VINYL EXAMINATION GLOVES (K033229) | Bernard Technologies, Inc. | 2003-12-17 |
| MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM (K033664) | Centerpulse Orthopedics, Inc. | 2003-12-17 |
| HEMADERM (K033666) | Medafor, Inc. | 2003-12-17 |
| MEDICAL IMAGE DIGITIZER, MODEL 2908 (K033637) | Array Corp. | 2003-12-17 |
| BAYER RAPIDLAB 1200 SYSTEM (K031560) | Bayer Healthcare, LLC | 2003-12-17 |
| FACTOR V LEIDEN KIT (DEN030005) | Roche Diagnostics Corp. | 2003-12-17 |
| STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS (K032943) | Stryker Corp. | 2003-12-17 |
| VENTURI PHACO PACK (K033653) | Bausch & Lomb, Inc. | 2003-12-17 |
| PROFEEL POWDER FREE, PLOYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE (K032942) | Wrp Asia Pacific Sdn. Bhd. | 2003-12-17 |
| MODIFICATION TO: NUCAMMA RX (K032779) | Is2 Research, Inc. | 2003-12-17 |
| B-TWIN BONE EXPANDER SYSTEM (B-TWIN BE SYSTEM) (K032358) | Disc-O-Tech Medical Technologies, Ltd. | 2003-12-17 |
| PALACOS R BONE CEMENT WITH GENTAMICIN (K030086) | Biomet, Inc. | 2003-12-17 |
| CONDUCTIVE EEG ELECTROLYTE (K033052) | Compumedics USA, Ltd. | 2003-12-17 |
| LIGHTCYCLER INSTRUMENT VERSION 1.2 (K033734) | Roche Diagnostics Corp. | 2003-12-17 |
| PELVIC ARRAY COIL (K033753) | Usa Instruments, Inc. | 2003-12-17 |
| GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL (K033235) | Usa Instruments, Inc. | 2003-12-17 |
| SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE (K033682) | Laboratorios Grifols, S.A. | 2003-12-17 |
| CONTOUR-FLEX VALVE AND SHUNT SYSTEM (K033698) | Integra Neurosciences Implants S.A. | 2003-12-17 |
| THAI NIPPON EXTRA STRENGTH MALE LATEX CONDOM (K032909) | Thai Nippon Rubber Industry Co., Ltd. | 2003-12-16 |
| THE COEUR INJECTOR ADAPTOR/PRESSURE JACKET, MODEL C859-6003 (K032920) | Coeur Medical | 2003-12-16 |
| EVOLVE (K033551) | Reliance Orthodontic Products, Inc. | 2003-12-16 |
| HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP (K033054) | Harvard Clinical Technology | 2003-12-16 |
| CLEANER II ROTATIONAL THROMBECTOMY SYSTEM (K033793) | Rex Medical | 2003-12-16 |
| INSORB ABSORBABLE STAPLE, MODEL SP-B20 (K033602) | Incisive Surgical, Inc. | 2003-12-16 |
| LOTUS (K032424) | Sra Developments, Ltd. | 2003-12-16 |
| BAYER SPECIAL CHEMISTRY CALIBRATORS (K033380) | Bayer Diagnostics Corp. | 2003-12-16 |
| GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING) (K032994) | Gemore Technology Co, Ltd. | 2003-12-16 |
| EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION (K032741) | Axon Systems, Inc. | 2003-12-16 |
| AESKULISA ANA 8PRO (K032469) | Aesku, Inc. | 2003-12-16 |
| PACS SOFTWARE SOLUTION 2003 (K033624) | Canon USA, Inc. | 2003-12-15 |
| SUBTALAR ARTHRORISIS IMPLANT (K032902) | Nexa Orthopedics, Inc. | 2003-12-15 |
| TRIDENT RESECTION ABLATOR (K033748) | Linvatec Corp. | 2003-12-15 |
| ACCUSOFT (K032171) | Direx Systems Corp. | 2003-12-15 |
| LORENZ STERNAL CLOSURE SYSTEM (K033740) | Walter Lorenz Surgical, Inc. | 2003-12-15 |
| MODIFICATION TO COATEST FACTOR VIII (K033631) | Instrumentation Laboratory CO | 2003-12-15 |
| AEQUALIS SHOULDER FRACTURE SYSTEM (K032679) | Tornier | 2003-12-15 |
| EUSOL-C (K032422) | Al.Chi.Mi.A | 2003-12-15 |
| PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS (K033306) | Roche Diagnostics Corp. | 2003-12-15 |
| MODIFICATION TO CD HORIZON SPINAL SYSTEM (K033322) | Medtronic Sofamor Danek | 2003-12-15 |
| ZILVER 518 BILIARY STENT (K033348) | Cook, Inc. | 2003-12-15 |
| AUTOMOVE, MODEL AM800 (K032955) | Danmeter A/S | 2003-12-15 |
| FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES (K033701) | Ciba Vision Corporation | 2003-12-15 |
| TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L (K033604) | Pie Medical | 2003-12-15 |
| ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE (K033299) | ACON Laboratories, Inc. | 2003-12-12 |
| LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454; POSITIVE, MODEL 455 (K033366) | Bio-Rad | 2003-12-12 |
| FASTRAC GASTRIC ACCESS PORT KIT (K033562) | C.R. Bard, Inc. | 2003-12-12 |
| BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540 (K033752) | Bruno Independent Living Aids, Inc. | 2003-12-12 |
| IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (K033234) | Diagnostic Products Corp. | 2003-12-12 |
| AMNIOLENS (K032104) | Bio-Tissue, Inc. | 2003-12-12 |
| LARYNGEAL AUGMENTATION IMPLANT (K033398) | Bioform, Inc. | 2003-12-12 |
| SIROSON L AND SIROSONIC L ULTRASONIC SCALERS (K033640) | Sirona Dental Systems GmbH | 2003-12-12 |
| AIACT KIT (K032952) | Sienco, Inc. | 2003-12-12 |
| TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA (K033230) | Parallax Medical, Inc. | 2003-12-12 |
| VERTELINK KOBRA SPINAL FIXATION SYSTEM (K032102) | Vertelink Corporation | 2003-12-12 |
| MISSION CONTROLS (K033063) | Diamond Diagnostics, Inc. | 2003-12-12 |
| KACEY INSULIN SYRINGE (K033166) | Kacey, Inc. | 2003-12-12 |
| TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 (K031812) | Vascular Control Systems, Inc. | 2003-12-12 |
| MOTILITY VISUALIZATION SYSTEM (K031169) | Sierra Scientific Instruments, Inc. | 2003-12-12 |
| VANTAGE PRO ATTENUATION CORRECTION DEVICE (K033735) | Adac Laboratories | 2003-12-12 |
| CLARITY PET (K032866) | Shared P.E.T. Imaging, LLC | 2003-12-12 |
| PROGREAT (K033583) | Terumo Medical Corp. | 2003-12-12 |
| LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) (K033404) | Bio-Rad | 2003-12-12 |
| SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS (K033298) | Masimo Corp. | 2003-12-12 |
| MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING (K033714) | Dideco S.P.A. | 2003-12-11 |
| ALT LASER, MODEL VTR 75 (K031612) | Avicenna Laser Technology, Inc. | 2003-12-11 |
| RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY (K032205) | Radiancy (Israel) , Ltd. | 2003-12-11 |
| MBCP (K032268) | Biomatlante | 2003-12-11 |
| H/S CATHETER SET (K032835) | Catheter Research, Inc. | 2003-12-11 |
| ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 (K033424) | Transonic Systems, Inc. | 2003-12-11 |
| SPECTRA PULSED DIODE LASER, MODEL DR-1 (K032846) | Spectragenics, Inc. | 2003-12-11 |
| INFINITY GAMMAXL (K033600) | Draeger Medical Systems, Inc. | 2003-12-11 |
| M2376A PHILIPS DEVICE LINK SYSTEM (K033680) | Philips Medical Systems | 2003-12-11 |
| GLIDESHEATH (K033681) | Terumo Corp. | 2003-12-11 |
| VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM (K031077) | Chattanooga Group | 2003-12-11 |
| SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 (K033641) | Cobe Cardiovascular, Inc. | 2003-12-11 |
| MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM (K033708) | Intra Luminal Therapeutics, Inc. | 2003-12-11 |
| SCORPIO LOW PROFILE TIBIAL TRAY (K032829) | Howmedica Osteonics Corp. | 2003-12-10 |
| IMMEDIATE STABILIZING IMPLANT (ISI) (K033392) | O Co., Inc. | 2003-12-10 |
| C-GRAFT (K033110) | The Clinician'S Preference, LLC | 2003-12-10 |
| TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700 (K033025) | Tytan Medical Corp. | 2003-12-10 |
| TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 (K031949) | Baylis Medical Co., Inc. | 2003-12-10 |
| MODIFICATION TO AURORA DS (K033586) | Syneron Medical, Ltd. | 2003-12-10 |