| GLASIONOMER FX-II (K031467) | Shofu Dental Corp. | 2003-07-17 |
| PHILLIPS OMNIDIAGNOST ELEVA (K032046) | Philips Medical Systems, Inc. | 2003-07-17 |
| POWER LASER 90 (K030692) | Andi Electromedical Aps | 2003-07-17 |
| CEFAR REHAB 2 AND REHAB 2 PRO (K030403) | Cefar Medical AB | 2003-07-17 |
| RX300 OXYGEN ANALYZER (K024228) | Teledyne Analytical Instruments | 2003-07-17 |
| OSTEO-G BONE VOID FILLER SYSTEM (K031319) | Aspine USA, Inc. | 2003-07-17 |
| RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER) (K031926) | Rita Medical Systems, Inc. | 2003-07-17 |
| MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE (K031216) | Aesculap | 2003-07-17 |
| MX 300 OXYGEN MONITOR (K024155) | Teledyne Analytical Instruments | 2003-07-17 |
| FERRITIN GENERATION 2 (K031650) | Roche Diagnostics Corp. | 2003-07-17 |
| XPECT INFLUENZA A/B (K031565) | Remel, Inc. | 2003-07-17 |
| UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED (K030158) | Walsh Medical Devices, Inc. | 2003-07-17 |
| CELLPLEX TCP SYNTHETIC CANCELLOUS BONE (K031817) | Wrightmedicaltechnologyinc | 2003-07-17 |
| MODIFICATION TO HERMES O.R. CONTROL CENTER (K031956) | Computer Motion, Inc. | 2003-07-17 |
| ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH (K031211) | Medtronic Vascular | 2003-07-17 |
| BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD (K031950) | Baylis Medical Co., Inc. | 2003-07-17 |
| COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER (K021841) | Pneupac , Ltd. | 2003-07-17 |
| DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES (K031376) | Ge Medical Systems Information Technologies | 2003-07-16 |
| ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE (K030960) | Acmi Corporation | 2003-07-16 |
| BIO-LOGIC INSERT EARPHONES (K031352) | Bio-Logic Systems Corp. | 2003-07-16 |
| OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE (K032092) | Olympus Optical Co., Ltd. | 2003-07-16 |
| AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL (K031880) | Roche Diagnostics Corp. | 2003-07-16 |
| SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE (K031545) | Trek Diagnostic Systems, Inc. | 2003-07-16 |
| BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM (K031679) | Becton, Dickinson & CO | 2003-07-16 |
| MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL (K031890) | Medical Analysis Systems, Inc. | 2003-07-16 |
| RUBELLACOL (K031490) | Immunostics Inc., | 2003-07-16 |
| PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE (K030939) | Philips Medical Systems | 2003-07-15 |
| FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II (K031016) | The Binding Site, Ltd. | 2003-07-15 |
| ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM (K031201) | Ortho Development Corp. | 2003-07-15 |
| VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 (K031844) | Boston Scientific Corp | 2003-07-15 |
| AMERITEK SURE-POINT HDR NEEDLE TEMPLATE (K031273) | Amertek Medical, Inc. | 2003-07-15 |
| MAYO CLINIC BC-10 1.5T (K031119) | Mayo Medical Ventures | 2003-07-15 |
| ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (K031044) | Clinical Data, Inc. | 2003-07-15 |
| CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF (K031416) | Clearmedical, Inc. | 2003-07-15 |
| ESTYLUS ELECTRIC MOTOR SYSTEM (K031145) | Dentsply Intl. | 2003-07-15 |
| B. BRAUN NERVE BLOCK CATHETER (K030830) | B.Braun Medical, Inc. | 2003-07-15 |
| DBC PRESS ACUPUNCTURE NEEDLES (K031250) | Lhasa Medical, Inc. | 2003-07-15 |
| SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT (K031870) | Beckman Coulter, Inc. | 2003-07-15 |
| SAFETY INTRODUCER NEEDLE (K030135) | B.Braun Medical, Inc. | 2003-07-15 |
| SAFETY RELEASE ARCH BAR KIT (K031207) | Casey Surgical, LLC | 2003-07-15 |
| FABIUS TIRO ANESTHESIA SYSTEM (K031400) | Draeger Medical, Inc. | 2003-07-15 |
| BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST (K031203) | DePuy Orthopaedics, Inc. | 2003-07-14 |
| EXTERNAL FIXATION SYSTEMS (K031181) | Smith & Nephew, Inc. | 2003-07-14 |
| SYNTHES SMALL COBINATION CLAMP-MR SAFE (K031724) | Synthes (Usa) | 2003-07-14 |
| SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J (K024007) | Sunder Biomedical Tech. Co., Ltd. | 2003-07-14 |
| VERDICT II, PROFILE II (K031032) | Medtox Diagnostics, Inc. | 2003-07-14 |
| ULTRAFLEX PRECISION COLONIC STENT (K030769) | Boston Scientific Corp | 2003-07-14 |
| PCW PERCUTANEOUS COMPRESSION WIRE (K031050) | Millennium Medical Technologies, Inc. | 2003-07-14 |
| TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE (K031183) | Centerpulse Orthopedics, Inc. | 2003-07-14 |
| BACT/ALERT MP CULTURE BOTTLES (PLASTIC) (K031737) | bioMerieux, Inc. | 2003-07-14 |
| ACON STREP A RAPID TEST DEVICE (K031784) | ACON Laboratories, Inc. | 2003-07-14 |
| INJECTOR (K023737) | Anton Meyer & Co. , Ltd. | 2003-07-14 |
| FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS (K031067) | First Quality Hygienic, Inc. | 2003-07-14 |
| VAXCEL WITH PASV PORT, MODEL 45-213 (K032008) | Boston Scientific Corp | 2003-07-14 |
| KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS (K030788) | Geister Medizin Technik GmbH | 2003-07-12 |
| SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE (K031914) | Spinal Concepts, Inc. | 2003-07-12 |
| TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS (K030703) | Home Diagnostics, Inc. | 2003-07-11 |
| NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES (K031060) | Lhasa Medical, Inc. | 2003-07-11 |
| GEMINI 16 (K032036) | Philips Medical Systems (Cleveland), Inc. | 2003-07-11 |
| A/C ENZYMATIC HOMOCYSTEINE ASSAY (K030754) | Anticancer, Inc. | 2003-07-11 |
| MEDRAD SWABBABLE VALVE TRANSFER SET (K031808) | Medrad, Inc. | 2003-07-11 |
| C. DIFF CHEK - 60 (K030992) | Techlab, Inc. | 2003-07-11 |
| TEMPORARY RESIN CEMENT (K031212) | Parkell, Inc. | 2003-07-11 |
| AUTION JET AJ-4270 URINE ANALYZER (K030600) | International Remote Imaging Systems | 2003-07-11 |
| VASC-ALERT (K030456) | Vasc-Alert, LLC | 2003-07-11 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE (K031589) | Becton, Dickinson & CO | 2003-07-11 |
| HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 (K031823) | Implex Corp. | 2003-07-11 |
| COOK GASTRIC SIZING BALLOON CATHETER (K030841) | Cook, Inc. | 2003-07-11 |
| OPTIBOLUS (K031339) | Mallinckrodt Inc., Liebel-Flarsheim Business | 2003-07-11 |
| MODIFICATION TO HERMES O.R. CONTROL CENTER (K031720) | Computer Motion, Inc. | 2003-07-11 |
| BUTLER GUM PROPHY PASTE WITH NOVAMIN (K024343) | Usbiomaterials Corp. | 2003-07-11 |
| PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL (K031366) | Usa Instruments, Inc. | 2003-07-11 |
| ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1 (K031417) | Intra Luminal Therapeutics, Inc. | 2003-07-11 |
| MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE (K030547) | Guardian Angel Products, Inc. | 2003-07-11 |
| C. DIFF CHEK - 30 (K030991) | Techlab, Inc. | 2003-07-11 |
| BODY SIGNAL ECG ELECTRODE (K031174) | Wandy Rubber Industrial Co., Ltd. | 2003-07-10 |
| GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03 (K031036) | Gebauer Co. | 2003-07-10 |
| EBI XFIX OPTIROM KNEE FIXATOR (K031093) | Ebi, L.P. | 2003-07-10 |
| SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE (K031716) | Asia-Med GmbH and CO KG | 2003-07-10 |
| CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE (K031482) | Cryomedical Instruemts , Ltd. | 2003-07-10 |
| RH-900 (K031115) | Iomed, Inc. | 2003-07-10 |
| VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE (K031410) | bioMerieux, Inc. | 2003-07-10 |
| 4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX (K030852) | Mogul Enterprises | 2003-07-10 |
| AEROLET TOILET LIFT, MODEL AER-01 (K031045) | Economic Holland B.V. | 2003-07-10 |
| X-PROT DUO PORT (K032044) | C.R. Bard, Inc. | 2003-07-10 |
| COACH 888W (K030760) | Wheelchair & Scooter Express | 2003-07-10 |
| IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 (K031059) | Ivd Research, Inc. | 2003-07-10 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML (K031530) | Becton, Dickinson & CO | 2003-07-10 |
| JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II (K031342) | Jason Marine Enterprises, Inc. | 2003-07-10 |
| IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR (K032040) | Dideco S.P.A. | 2003-07-09 |
| COBAS INTEGRA CHOLESTEROL GEN. 2 (K031824) | Roche Diagnostics Corp. | 2003-07-09 |
| DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML (K030638) | Avantec Vascular Corp. | 2003-07-09 |
| VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR (K031913) | Arista Latindo Industrial Ltd. P.T | 2003-07-09 |
| TELZUIT CARDIAC MONITORING SYSTEM (K031229) | Telzuit Technologies, Inc. | 2003-07-09 |
| ENTERALITE INFINITY ENTERAL FEEDING PUMP (K031199) | Zevex Intl., Inc. | 2003-07-09 |
| PROPHYPEARLS (K031868) | Kavo America | 2003-07-09 |
| SUILE WOUND DRESSING (K022967) | Hedonist Biochemical Technologies Co., Ltd. | 2003-07-08 |
| CYNOSURE PHOTOLIGHT PL (K031258) | Cynosure, Inc. | 2003-07-08 |
| CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM) (K031690) | Cynosure, Inc. | 2003-07-08 |
| THE SUAD DEVICE (K023836) | Strong Dental, Inc. | 2003-07-08 |