| ADAM (K033978) | Astro-Med, Inc. | 2004-02-18 |
| COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0 (K040104) | Boston Scientific Corp | 2004-02-18 |
| SPINAL CONCEPTS INC. CADENCE AND TRAXIS (K033517) | Spinal Concepts, Inc. | 2004-02-18 |
| MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER (K040150) | Medamicus, Inc. | 2004-02-18 |
| ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS (K033223) | Zimmer, Inc. | 2004-02-18 |
| C.T.M. POWER CHAIR, MODEL HS-1000 (K040020) | C.T.M. Homecare Product, Inc. | 2004-02-18 |
| VASCON POLARIS GUIDING CATHETER (K033633) | Vascon, LLC | 2004-02-18 |
| ENDOBIONICS MICROSYRINGE (USYRINGE) INFUSION CATHETER (K040139) | Endobionics, Inc. | 2004-02-18 |
| FEMTEC LASER MICROKERATOME (K033354) | 20/10 Perfect Vision Optische Gerate GmbH | 2004-02-18 |
| CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT (K031859) | Arthrosurface, Inc. | 2004-02-18 |
| ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE (K032903) | ACON Laboratories, Inc. | 2004-02-17 |
| PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 (K032958) | United Medical Systems, Inc. | 2004-02-17 |
| MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM (K040248) | Given Imaging , Ltd. | 2004-02-17 |
| VECTORVISION CRANIAL/ENT (K023651) | Brainlab AG | 2004-02-17 |
| ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE (K033768) | Altus Medical, Inc. | 2004-02-17 |
| SUPRAFLOW CONSOLE (K040239) | Neomedix Corp. | 2004-02-17 |
| QLAB QUANTIFICATION SOFTWARE (K040227) | Philips Ultrasound | 2004-02-17 |
| ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE (K033047) | ACON Laboratories, Inc. | 2004-02-17 |
| WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM (K033909) | Abbott Laboratories | 2004-02-17 |
| MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055 (K034036) | Micro Therapeutics, Inc. | 2004-02-13 |
| TITANIUM TOGGLE BUTTON(S) (K033838) | Biomet Manufacturing, Inc. | 2004-02-13 |
| HEMOSIL FACTOR VIII DEFICIENT PLASMA (K034007) | Instrumentation Laboratory CO | 2004-02-13 |
| MICROSTAT PVA FOAM EMBOLIZATION PARTICLES (K032619) | Surgica Corp. | 2004-02-13 |
| PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER (K033715) | Philips Medical Systems, Inc. | 2004-02-13 |
| NOVOSCI READY SYSTEM, MODEL RS-200 (K033270) | Novosci Corp. | 2004-02-13 |
| BAYER SPECIFIC PROTEIN REFERENCE SERUM (K033791) | Bayer Healthcare, LLC | 2004-02-13 |
| OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI (K033883) | Exactech, Inc. | 2004-02-13 |
| ECHO SOUNDER EX-101EX 8 MHZ (K031931) | Koven Technology, Inc. | 2004-02-13 |
| BARD ATLAS PTA BALLOON DILATATION CATHETER (K040243) | C.R. Bard, Inc. | 2004-02-13 |
| CANNON II PLUS (K040078) | Arrow International, Inc. | 2004-02-13 |
| ELECSYS C-PEPTIDE CALSET (K033873) | Roche Diagnostics Corp. | 2004-02-13 |
| PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT INTRODUCERS FOR SIZES 7, 8 AND 9MM TUBES ONLY (K040014) | Portex , Ltd. | 2004-02-13 |
| LEVIA PHOTOTHERAPY SYSTEM (K040062) | Lerner Medical Devices, Inc. | 2004-02-13 |
| VICEROY INFLATION DEVICE (K040138) | Merit Medical Systems, Inc. | 2004-02-13 |
| VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT (K033721) | Vascular Solutions, Inc. | 2004-02-13 |
| EIUS UNICOMPARTMENTAL KNEE SYSTEM (K033769) | Howmedica Osteonics Corp. | 2004-02-13 |
| THE ULTRA SYSTEM SP (K032813) | Promedica, Inc. | 2004-02-13 |
| INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION (K031745) | Sensor Medics Corp. | 2004-02-13 |
| WFSI'S REPROCESSED COMPRESSION SLEEVE DEVICES (K033615) | Wheaton Franciscan Services Inc., Supply Chain | 2004-02-13 |
| MEDLINE STRIDER MIDI 3 (K040097) | Medline Industries, Inc. | 2004-02-13 |
| MODIFICATION TO CD HORIZON SPINAL SYSTEM (K040072) | Medtronic Sofamor Danek, Inc. | 2004-02-12 |
| SIREMOBILE C06 (K040066) | Siemens Medical Solutions USA, Inc. | 2004-02-12 |
| ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS (K033011) | Zimmer, Inc. | 2004-02-12 |
| TITANIUM MESH SYSTEM (K032371) | Encore Medical L.P. | 2004-02-12 |
| VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC (K040118) | Vascular Solutions, Inc. | 2004-02-12 |
| IQ GUIDE WIRE (K040140) | Boston Scientific Corp | 2004-02-12 |
| LEKSELL SURGIPLAN WITH IMAGEMERGE (K033340) | Elekta Instrument AB | 2004-02-12 |
| LIAISON N-TACT PTH (K033426) | DiaSorin, Inc. | 2004-02-12 |
| PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYSTEM (K032815) | Precision Surgery Limited | 2004-02-12 |
| MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE (K033718) | Arthrotek, Inc. | 2004-02-12 |
| LIAISON 25 OH VITAMIN D (K032844) | DiaSorin, Inc. | 2004-02-12 |
| MEDLINE STRIDER, MODELS MIDI 3 AND MIDI 4 (K032446) | Medline Industries, Inc. | 2004-02-12 |
| WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 (K023889) | Wiener Laboratories Saic | 2004-02-11 |
| OMRON INTELLISENSE DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-907XL (K032305) | Omron Healthcare, Inc. | 2004-02-11 |
| BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER (K040034) | Blackstone Medical, Inc. | 2004-02-11 |
| LINVATEC 10K IRRIGATION SYSTEM (K033573) | Linvatec Corp. | 2004-02-11 |
| SYSMEX POCH-100I (K032677) | Sysmex America, Inc. | 2004-02-11 |
| TRIO MONITOR MODEL 0998-00-0600 (K032338) | Datascope Corp. | 2004-02-11 |
| LABONE MICRO-PLATE COTININE EIA (K033601) | Labone, Inc. | 2004-02-10 |
| MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY (K032067) | Proxima Therapeutics, Inc. | 2004-02-10 |
| CURAD SILVER BANDAGE (K032463) | Beiersdorf AG | 2004-02-10 |
| CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER (K033840) | CellaVision AB | 2004-02-10 |
| MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML (K032706) | Dade Behring, Inc. | 2004-02-10 |
| CURAD SILVER ACTIVE GEL BANDAGE (K032462) | Beiersdorf AG | 2004-02-10 |
| POLARCATH PERIPHERAL DILATATION SYSTEM (K033622) | Cryo Vascular Systems, Inc. | 2004-02-10 |
| MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK (K033941) | Bausch & Lomb, Inc. | 2004-02-10 |
| CAPIOX CARDIOTOMY RESERVOIR (K033800) | Terumo Cardiovascular Systems Corporation | 2004-02-10 |
| CSTAT, MODELS 09-0014-01 AND 09-0014-02 (K032125) | Vascular Control Systems, Inc. | 2004-02-09 |
| MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 (K031741) | Alaris Medical Systems, Inc. | 2004-02-09 |
| ONE.CLICK NEEDLE (K033575) | B.Braun Medical, Inc. | 2004-02-09 |
| APOGEE ELITE (K034030) | Cynosure, Inc. | 2004-02-09 |
| MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS (K033674) | Seradyn, Inc. | 2004-02-09 |
| URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A (K033713) | Dade Behring, Inc. | 2004-02-09 |
| CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS (K033213) | Codent Technical Industry Co., Ltd. | 2004-02-06 |
| ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE (K040142) | Adac Laboratories | 2004-02-06 |
| HERMES BOND (K033974) | 3M Espe AG Dental Products | 2004-02-06 |
| IDEAL 1 ORTHODONTIC BRACKET ADHESIVE (K033703) | Dentsply Intl. | 2004-02-06 |
| BAWMED E-Z BAG RESUSCITATOR (K031434) | Bawmed UK | 2004-02-06 |
| RESPIRONICS CUSTOM I ORAL APPLIANCE (K033822) | Respironics, Inc. | 2004-02-06 |
| RESPIRONICS CUSTOM II ORAL APPLIANCE (K033823) | Respironics, Inc. | 2004-02-06 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO) (K034060) | Hong Huang Tang Industrial Co., Ltd. | 2004-02-06 |
| VOLAR RADIUS PLATE WITH ANGULAR STABILITY (K033756) | I.T.S. Implantat-Technologie-Systeme GmbH | 2004-02-06 |
| SEDLINE WITH FRONTAL PSI (K033999) | Physiometrix, Inc. | 2004-02-06 |
| PROCEARA COPINGS AND PONTIC (K032562) | Nobel Biocare AB | 2004-02-06 |
| TEETH IN AN HOUR - ARK IMPLANT CONCEPT (K030685) | Nobel Biocare AB | 2004-02-06 |
| SMARTSET GHV GENTAMICIN BONE CEMENT (K033563) | DePuy Orthopaedics, Inc. | 2004-02-05 |
| QCA (VERSION 3.1) (K031363) | Cell Analysis, Inc. | 2004-02-05 |
| SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM (K033844) | Synthes (Usa) | 2004-02-05 |
| MODIFICATION TO DIADEXUS PLAC TEST (K040101) | Diadexus, Inc. | 2004-02-05 |
| ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES (K033777) | Syntex Healthcare Products Co., Ltd. | 2004-02-05 |
| HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM (K033089) | Gyrus Ent LLC | 2004-02-05 |
| INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER (K033527) | B.Braun Medical, Inc. | 2004-02-05 |
| INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X) (K032631) | Lac Mac, Ltd. | 2004-02-05 |
| SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT (K033382) | DePuy Orthopaedics, Inc. | 2004-02-05 |
| HEARTRAK SMART AT/HEARTRAK SMART2 (K033451) | Universal Medical, Inc. | 2004-02-05 |
| DEPUY SIGMA TIBIAL INSERTS (K033272) | DePuy Orthopaedics, Inc. | 2004-02-05 |
| VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN (K032416) | Shofu Dental Corp. | 2004-02-05 |
| MOSSMED DUAL INTERMITTENT ASPIRATOR (K031492) | Moss Medical Products | 2004-02-05 |
| TRIMED RADIAL BULLET (K030877) | Tri-Med, Inc. | 2004-02-05 |
| 40 L HIGH FLOW INSUFFLATOR F108 (K030837) | W.O.M. World of Medicine AG | 2004-02-05 |