| XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 (K031942) | Remel, Inc. | 2003-11-18 |
| ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS (K031666) | Arthrex, Inc. | 2003-11-18 |
| ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 (K032784) | Intra Luminal Therapeutics, Inc. | 2003-11-18 |
| SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES (K031553) | Arcadia Medical Corporation | 2003-11-18 |
| PASCO MIC AND MIC/ID PANELS (K033119) | Pasco Laboratories, Inc. | 2003-11-18 |
| BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER (K033350) | Becton, Dickinson & CO | 2003-11-18 |
| MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT (K033473) | Horizon Medical Products, Inc. | 2003-11-18 |
| GLUCOSE TOLERANCE BEVERAGE (K032753) | Perk Scientific, Inc. | 2003-11-18 |
| DELTA SHOULDER (K021478) | Depuy, Inc. | 2003-11-18 |
| MARINA MEDICAL SILICONE PESSARY (K031463) | Marina Medical Instruments, Inc. | 2003-11-18 |
| PARADIGMPAL, MODEL MMT-7330 (K031541) | Minimed, Inc. | 2003-11-18 |
| ORTHODEK (K033115) | Teleflex Medical | 2003-11-17 |
| ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005 (K032987) | Unotech Diagnostics, Inc. | 2003-11-17 |
| CYNOSURE PHOTOGENICA SV LASER (K032539) | Cynosure, Inc. | 2003-11-17 |
| MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM (K033134) | Ev3, Inc. | 2003-11-17 |
| AURA ISURGICAL LASER SYSTEM & ACCESSORIES (K024206) | Laserscope | 2003-11-17 |
| STONE EXTRACTOR BALLOON CATHETER (K011261) | Medi-Globe Corp. | 2003-11-17 |
| GYRUS OPEN FORCEPS (K024286) | Gyrus Medical, Inc. | 2003-11-17 |
| CAPROSYN ABSORBABLE SUTURE (K032586) | United States Surgical, A Division of Tyco Healthc | 2003-11-17 |
| ARTELON SURGICAL SUTURE (K032160) | Artimplant AB | 2003-11-17 |
| OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) (K031380) | Olympus America, Inc. | 2003-11-14 |
| CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000 (K033358) | Surgitech, Inc. | 2003-11-14 |
| AUTO-BAND LIGATOR (K031236) | Scandimed. A.S. | 2003-11-14 |
| PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED) (K032636) | Playtex Products, Inc. | 2003-11-14 |
| BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM (K033007) | Bayer Diagnostics Corp. | 2003-11-14 |
| SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES (K032543) | Sirona Dental Systems GmbH | 2003-11-14 |
| BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03 (K031646) | Bausch & Lomb, Inc. | 2003-11-14 |
| AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE (K033468) | Medtronic Perfusion Systems | 2003-11-14 |
| SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B (K033333) | Aomori Olympus Co., Ltd. | 2003-11-14 |
| KWIKEZE MALE CONDOM APPLICATOR (K031007) | Condax, LLC | 2003-11-14 |
| SPIROPRO SPO2 (K031515) | Viasys Healthcare GmbH | 2003-11-14 |
| MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 (K031024) | Microlife Corp. | 2003-11-14 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA GREEN COLOR (K032670) | Kingswell International, Inc. | 2003-11-14 |
| XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 (K031965) | Remel, Inc. | 2003-11-14 |
| MOBILETTE XP AND MOBILETT XPHYBRID (K033238) | Siemens Medical Systems, Inc. | 2003-11-14 |
| DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS (K033329) | Depuy, Inc. | 2003-11-14 |
| PASCAL DYNAMIC CONTOUR TONOMETER (K032967) | Smt Swiss Microtechnology AG | 2003-11-14 |
| PASSMED SPINAL SYSTEM (K032094) | Medicrea | 2003-11-14 |
| MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE (K032777) | Nipro Medical Corp. | 2003-11-14 |
| BARD ENDOTRACHEAL TUBE, CUFFED (K030792) | C.R. Bard, Inc. | 2003-11-14 |
| MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES (K033353) | Usa Instruments, Inc. | 2003-11-14 |
| SHILEY FLEXTRA TRACHEOSTOMY TUBE (K030787) | Nellcor Puritan Bennett, Inc. | 2003-11-14 |
| CLICK'X MONOAXIAL SCREWS AND HOOKS (K031175) | Synthes (Usa) | 2003-11-14 |
| ACCUMAP AUTOMATIC PERIMETER (K022304) | Objectivision Pty , Ltd. | 2003-11-14 |
| BARD DUAL LUMEN URETERAL CATHETER (K032521) | C.R. Bard, Inc. | 2003-11-14 |
| NAVIGATOR I (K032879) | Adaptive Healthcare Technologies, Inc. | 2003-11-13 |
| NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY (K032444) | Cardinalhealth | 2003-11-13 |
| PROFILE BBL SYSTEM (K032460) | Sciton, Inc | 2003-11-13 |
| DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES (K033144) | Defibtech, LLC | 2003-11-13 |
| STELKAST UNICONDYLAR KNEE SYSTEM (K032824) | Stelkast Company | 2003-11-13 |
| NUVASIVE MESH (K032476) | Nuvasive, Inc. | 2003-11-13 |
| HOSPITAL SPACER (K032809) | Respironics Healthscan, Inc. | 2003-11-13 |
| BLUE SAIL (BRAND) POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K032781) | Zibo Blue Sail Plastic & Rubber Products Co., Ltd. | 2003-11-13 |
| POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE BROTHERS (K031170) | Long First (Xiamen) Co., Ltd. | 2003-11-13 |
| MPS ACACIA SAFEGUARD HUBER DEVICE (K032934) | Mps Acacia | 2003-11-13 |
| COPC BAND (K021594) | Center For Orthotic and Prosthetic Care,Llc | 2003-11-13 |
| DENTATUS OSCIOMAT (K031793) | Dentatus USA , Ltd. | 2003-11-13 |
| ZOLL AUTOCLAVABLE INTERNAL HANDLES (K032691) | Zoll Medical Corp | 2003-11-13 |
| BLUE SAIL (BRAND) POWDERED VINYL PATIENT EXAMINATION GLOVES (K032783) | Zibo Blue Sail Plastic & Rubber Products Co., Ltd. | 2003-11-13 |
| PREMISE (K032921) | Sybron Dental Specialties, Inc. | 2003-11-13 |
| ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM (K032744) | Alveolus, Inc. | 2003-11-13 |
| RAINBOW GT-4A PAIN RELIEF MACHINE (K031546) | Sino-Us Information, Inc. | 2003-11-13 |
| EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS (K032964) | Exactech, Inc. | 2003-11-13 |
| MODIFICATION TO STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM (K033252) | Stryker Endoscopy | 2003-11-13 |
| APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (K033446) | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-13 |
| MONOJECT INSULIN SYRINGE (K033373) | Tyco Healthcare | 2003-11-13 |
| RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES (K031559) | Renu Medical, Inc. | 2003-11-12 |
| ORTRAUTEK TRAUMA SYSTEM (K032520) | Tekka | 2003-11-12 |
| ELECSYS PROBNP IMMUNOASSAY (K032646) | Roche Diagnostics Corp. | 2003-11-12 |
| TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02 (K033097) | Taiwan King Strong Co., Ltd. | 2003-11-12 |
| KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY TRANSFER PADS (K033021) | Kimberly-Clark Corp. | 2003-11-12 |
| MODIFICATION TO DASH 3000/4000 PATIENT MONITOR (K033304) | Ge Medical Systems Information Technologies | 2003-11-12 |
| OXYCON MOBILE (K023120) | Erich Jaeger GmbH | 2003-11-12 |
| ENDO PAT 2000 (K032519) | Itamar Medical | 2003-11-12 |
| MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881 (K031799) | Miele, Inc. | 2003-11-12 |
| ESG 4-WHEEL SCOOTER, ESG-03 (K033204) | Emg Technology Co., Ltd. | 2003-11-12 |
| BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600 (K033219) | Tung Keng Enterprise Co., Ltd. | 2003-11-12 |
| VITEK 2 GRAM NEGATIVE MOXIFLOXACIN (K032861) | bioMerieux, Inc. | 2003-11-12 |
| MODIFICATION TO: HI-ART SYSTEM (K033347) | Tomotherapy Incorporated | 2003-11-12 |
| GOOD MORNING TEST (K031798) | Standard Diagnostics, Inc. | 2003-11-12 |
| Y.E.S. POWERED WHEELCHAIR, MODEL T200 (K032669) | Yeou Eir Shuen Machinery Co., Ltd. | 2003-11-12 |
| DOC'S BEST WHITE COPPER CEMENT (K031494) | Cooley & Cooley, Ltd. | 2003-11-12 |
| Y.E.S POWERED WHEELCHAIR. T180 (K032512) | Yeou Eir Shuen Machinery Co., Ltd. | 2003-11-12 |
| WU'S 4-WHEELED SCOOTER, WT-L4JR (K032617) | Wu'S Tech Co., Ltd. | 2003-11-12 |
| BESTALOY (K033434) | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-12 |
| MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100 (K032852) | Revivant Corp. | 2003-11-12 |
| E-SARANG 86, DM78, DM55 (K033435) | We Dong Myung Dental Industrial Co., Ltd. | 2003-11-12 |
| BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500 (K033239) | Tung Keng Enterprise Co., Ltd. | 2003-11-12 |
| ULTRADENT CITRIC ACID 10% SOLUTION (K032627) | Ultradent Products, Inc. | 2003-11-12 |
| COMPACT DIGITAL CARDIAC CAMERA (CDCC) (K033199) | Is2 Medical Systems, Inc. | 2003-11-12 |
| ELECTRONIC MUSCLE MASSAGE, MODELS BE-550 AND BE-660 (K031820) | Multinational | 2003-11-12 |
| XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM (K033066) | Xitec Holdings, LLC | 2003-11-12 |
| POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE (K030583) | Shen Wei (Usa), Inc. | 2003-11-10 |
| XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY (K031834) | Remel, Inc. | 2003-11-10 |
| ANZAI AZ-733 RESPIRATORY GATING SYSTEM (K031385) | Anzai Medical Co., Ltd. | 2003-11-10 |
| TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS (K033418) | Toshiba America Medical Systems, In.C | 2003-11-10 |
| SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION (K032536) | Siemens Medical Solutions USA, Inc. | 2003-11-10 |
| ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM (K033393) | Guidant Corp. | 2003-11-10 |
| BE-MOBILE 3-WHEELED ELECTRIC SCOOTER, MODEL DK S320 (K033241) | Tung Keng Enterprise Co., Ltd. | 2003-11-10 |
| PLANET MONITORING SYSTEM (K032871) | Larsen & Toubro Limited | 2003-11-10 |