| TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 (K032170) | Medical Industries America, Inc. | 2004-05-28 |
| PROCERA BRIDGE ZIRCONIA (K041283) | Nobel Biocare AB | 2004-05-28 |
| TECRES SPACER-K TEMPORARY KNEE PROSTHESIS (K032522) | Exactech, Inc. | 2004-05-28 |
| LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401 (K040512) | Well-Life Healthcare, Inc. | 2004-05-27 |
| CT COLONOGRAPHY II (K041270) | General Electric Medical Systems | 2004-05-27 |
| SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER (K031738) | Smiths Medical MD, Inc. | 2004-05-27 |
| CARDIQ ANALYSIS III (K041267) | General Electric Medical Systems | 2004-05-27 |
| MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA (K041227) | Roche Diagnostics Corp. | 2004-05-27 |
| POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS (K040914) | Exero Products, Inc. | 2004-05-27 |
| DUAL YELLOW LASER, MODEL DUAL YELLOW D10B (K032397) | Norseld Pty., Ltd. | 2004-05-27 |
| PROCERA ABUTMENT OCTAGON (K041275) | Nobel Biocare Uas, Inc. | 2004-05-27 |
| DRI OXYCODONE ASSAY (K040411) | Microgenics Corp. | 2004-05-27 |
| MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM (K040581) | Vitel Net | 2004-05-27 |
| PORTA REFLEX (K040672) | Wieland Dental + Technik GmbH & Co. KG | 2004-05-27 |
| MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS (K033704) | Vygon Us, LLC | 2004-05-27 |
| C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL ELISA KIT MODEL; CDIFF-96 (K032897) | Ivd Research, Inc. | 2004-05-27 |
| COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS) (K040090) | Pneupac , Ltd. | 2004-05-27 |
| AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT (K041160) | Howmedica Osteonics Corp. | 2004-05-27 |
| SPINAL CONCEPTS INC. CODA (K033663) | Spinal Concepts, Inc. | 2004-05-27 |
| PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 (K041236) | Nobel Biocare AB | 2004-05-26 |
| IMPAX CLIENT EMBRACE (K040555) | Agfa Corp. | 2004-05-26 |
| ZARGIS ACOUSTIC CARDIOSCAN (K031517) | Zargis Medical Corp. | 2004-05-26 |
| PHOTOSILK PULSED LIGHT SYSTEM (K041095) | Cynosure, Inc. | 2004-05-26 |
| FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR (K040246) | Fukuda Denshi USA, Inc. | 2004-05-26 |
| MODIFICATION TO NXSTAGE SYSTEM ONE (K040696) | Nxstage Medical, Inc. | 2004-05-26 |
| MEDLINE STRIDER MAXI 3 (K041054) | Medline Industries, Inc. | 2004-05-25 |
| ECONOLITH E3000, MODEL 3000 (SW-6) (K040461) | Medispec, Ltd. | 2004-05-25 |
| MEDLINE STRIDER MAXI 4 (K041055) | Medline Industries, Inc. | 2004-05-25 |
| METACRYL (K040881) | Great Lakes Orthodontics, Ltd. | 2004-05-25 |
| ARTHROTEK LACTONAIL (K040500) | Arthrotek, Inc. | 2004-05-25 |
| TRIGEN ADOLESCENT TAN (K040929) | Smith & Nephew, Inc. | 2004-05-25 |
| TRIDENT T ACETABULAR SHELLS (K040412) | Stryker Orthopaedics | 2004-05-25 |
| MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS (K032914) | Raven Biological Laboratories, Inc. | 2004-05-25 |
| MEDLINE STRIDER MICRO 3 (K041053) | Medline Industries, Inc. | 2004-05-25 |
| SMARTLANK WIRELESS, MODEL 001970 (K033642) | Mrl, A Welch Allyn Company | 2004-05-25 |
| MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW (K040656) | Smith & Nephew, Inc. | 2004-05-25 |
| SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150 (K040995) | Analogic Corp. | 2004-05-25 |
| REFOBACIN -PALACOS G (K031673) | Heraeus Kulzer GmbH & Co. KG | 2004-05-25 |
| M2 COMPATIBLE MICROKERATOME BLADE (K033457) | Micro Specialties, Inc. | 2004-05-25 |
| JMS BYPASS TUBE (K032977) | Jms North America Corp. | 2004-05-25 |
| A&I POWER WHEELCHAIR, PC-401 (K041190) | Well Success Biotech, Inc. | 2004-05-25 |
| SONOTRAX ULTRASONIC POCKET DOPPLER (K040480) | Edan Instruments, Inc. | 2004-05-25 |
| A&I SCOOTER, SC-301 (K041187) | Well Success Biotech, Inc. | 2004-05-25 |
| SIMPLANT SYSTEM (K033849) | Materialise NV | 2004-05-25 |
| A&I SCOOTER, SC-402 (K041193) | Well Success Biotech, Inc. | 2004-05-25 |
| TRANSXCHANGE SUPPORT CATHETER (K033540) | Medtronic Vascular | 2004-05-25 |
| SIMPLEX X (K032945) | Stryker Corp. | 2004-05-25 |
| HEARTSINE SAMARITAN PAD (K041067) | Heartsine Technologies, Inc. | 2004-05-25 |
| KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 (K040378) | Eastman Kodak Company | 2004-05-24 |
| PHOSPHOPLASTIN RL (K040296) | R2 Diagnostics, Inc. | 2004-05-24 |
| THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A (K041152) | Applied Diabetes Research, Inc. | 2004-05-24 |
| RTA MODEL D RETINAL THICKNESS ANALYZER (K041290) | Talia Technology , Ltd. | 2004-05-24 |
| I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP) (K040337) | I-Flow Corp. | 2004-05-24 |
| RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT (K041295) | Institut Straumann AG | 2004-05-24 |
| GRIFFIN SPECT/CT IMAGING SYSTEM (K041218) | Adac Laboratories | 2004-05-24 |
| POLYFLUX 14L, 17L, 21L HEMODIALYZER/FILTER LABELED FOR SINGLE USE (K040255) | Gambro Renal Products, Inc. | 2004-05-24 |
| INTEGRITY TEMPORARY CEMENT (K040895) | Dentsply Intl. | 2004-05-21 |
| ZOLL AED PLUS (K033474) | Zoll Medical Corp | 2004-05-21 |
| MAXIM ACCEL (VANGUARD) PS+ BEARINGS (K041046) | Biomet, Inc. | 2004-05-21 |
| ALM X'TEN (X10) SURGICAL LIGHT SYSTEM (K040735) | Alm S.A. | 2004-05-21 |
| VITALAB IRON REAGENT (K033983) | Clinical Data, Inc. | 2004-05-21 |
| MODEL 509M PULSE OXIMETER, MODEL 509M (K032755) | Respironics Novametrix, Inc. | 2004-05-21 |
| MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715 (K040676) | Medtronic Minimed | 2004-05-21 |
| Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM (K033627) | Biomedix, Inc. | 2004-05-21 |
| SYNTEGRA (K041182) | Adac Laboratories | 2004-05-21 |
| ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE (K040639) | Isurgical | 2004-05-21 |
| CELSIUS CONTROL SYSTEM (K033623) | Innercool Therapies, Inc. | 2004-05-21 |
| CRYMED CRYO-ABLATOR (K040809) | Crymed Technologies, Inc. | 2004-05-21 |
| RINSPIRATION SYSTEM (K041291) | Kerberos Proximal Solutions, Inc. | 2004-05-21 |
| GLUCATELL (DEN040003) | Associates of Cape Cod, Inc. | 2004-05-21 |
| NOA III ENTERAL NUTRITION PUMP (K040957) | Caesarea Medical Electronics , Ltd. | 2004-05-21 |
| I-TEC PORTABLE DENTAL OPERATORY (K040153) | Indigenous Peoples Technology and Education Center | 2004-05-21 |
| DOCUMENT SALICYLATE CAL VER (K041073) | Microgenics Corp. | 2004-05-21 |
| MICROMAX SUTURE ANCHOR (K040475) | Biomet, Inc. | 2004-05-21 |
| GELWEAVE ANTE-FLO WITH COLLAR AND GELWEAVE 4 BRANCH PLEXUS WITH COLLAR (K040829) | Vascutek, Ltd. | 2004-05-20 |
| LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITOR (K033899) | Lifestream Technologies, Inc. | 2004-05-20 |
| SLIP UROLOGY INTRODUCER SHEATH (K040520) | Percutaneous Systems, Inc. | 2004-05-20 |
| SLIP UROLOGY CATHETER (K040519) | Percutaneous Systems, Inc. | 2004-05-20 |
| L-TENS (K041164) | Fuji Dynamics Limited | 2004-05-20 |
| STARDUST II, MODEL 1011176 (K021845) | Respironics, Inc. | 2004-05-20 |
| WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH (K040324) | Wilson-Cook Medical, Inc. | 2004-05-20 |
| PROTEX STABILIZATION SYSTEM (K040442) | Globus Medical, Inc. | 2004-05-20 |
| COMBI SELF PROPELLED SHOWER COMMODE (K040677) | Kjaerulff Rehabilitation A/S | 2004-05-20 |
| CLINICAL LABORATORY ANALYZING SYSTEM (K041230) | Hemocue, Inc. | 2004-05-20 |
| PORTA SOLDER 1090 W (K040524) | Wieland Dental + Technik GmbH & Co. KG | 2004-05-20 |
| ONE-STEP PREGNANCY TEST (K041273) | W.H.P.M., Inc. | 2004-05-20 |
| PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 (K040575) | Phamatech, Inc. | 2004-05-20 |
| HERACERAM PRESS (K040859) | Heraeus Kulzer, Inc. | 2004-05-20 |
| TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR (K041006) | Kendall | 2004-05-19 |
| BONE CEMENT FOR CRANIOPLASTY (K040152) | Cardinalhealth | 2004-05-19 |
| SR ADORO (K040951) | Ivoclar Vivadent, Inc. | 2004-05-19 |
| NOMAD FROM DYNAMIS MOBILITY LTD. (K040457) | Dynamis Mobility , Ltd. | 2004-05-19 |
| A & D MEDICAL UA-767BT DIGITAL BLOOD PRESSURE MONITOR (K040371) | A&D Engineering, Inc. | 2004-05-19 |
| POWERED WHEELCHAIR (K033142) | Nats Corp. | 2004-05-19 |
| LIQUICHEK TORCH PLUS IGM CONTROL (K040822) | Bio-Rad Laboratories, Inc. | 2004-05-19 |
| PARADIGM LINK BLOOD GLUCOSE METER (K040603) | Becton, Dickinson & CO | 2004-05-19 |
| CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET (K040636) | Smiths Medical MD, Inc. | 2004-05-19 |
| BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) (K033885) | Lin-Zhi International, Inc. | 2004-05-19 |
| MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY (K033688) | Micro Direct, Inc. | 2004-05-19 |
| SINON (K040433) | Wavelight Laser Technologie AG | 2004-05-19 |