| VARI-ABLE APB (ADAPTABLE POSITIONING BASE) (K042401) | American Track Roadsters, Inc. | 2004-10-07 |
| ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES (K041163) | Isopure, Corp. | 2004-10-07 |
| JAZZY 600 (K042612) | Pride Mobility Products Corp. | 2004-10-06 |
| STAT K IN VITRO DIAGNOSTIC TEST SYSTEM (K042270) | Stat Chem, Inc. | 2004-10-06 |
| HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE (K042609) | Hospira, Inc. | 2004-10-06 |
| BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER (K042469) | Braemar, Inc. | 2004-10-06 |
| EQUI-FLOW VALVE AND SHUNT SYSTEM (K042558) | Integra Neurosciences Implants S.A. | 2004-10-06 |
| STELLAR 404 MONITORING SYSTEM (K042560) | Larsen & Toubro Limited | 2004-10-06 |
| CARDEON COBRA CATHETER (K042156) | Cardeon Corp. | 2004-10-06 |
| EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE (K042060) | Millimed A/S | 2004-10-06 |
| VACUUM ASSISTED CORE BIOPSY DEVICE (K042290) | Suros Surgical Systems, Inc. | 2004-10-06 |
| BALANCEBACK VNG SYSTEM (K042529) | Fall Prevention Technologies, LLC | 2004-10-06 |
| VERIFYNOW-ASPIRIN ASSAY (K042423) | Accumetrics, Inc. | 2004-10-06 |
| SLEEPSENSE SLEEP SENSORS (K042253) | S.L.P. , Ltd. | 2004-10-06 |
| VECTORVISION UNI-KNEE (K041899) | Brainlab AG | 2004-10-06 |
| MPM SYSTEM (K041854) | Aerotel Medical Systems, Ltd. | 2004-10-06 |
| LASEREX, MODEL LP4532 (K041598) | Ellex Medical Pty, Ltd. | 2004-10-06 |
| INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 (K042656) | Draeger Medical Systems, Inc. | 2004-10-06 |
| MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM (K041994) | Curelight, Ltd. | 2004-10-06 |
| NP-2600 SERIES HARDCOPY PRINTERS (K042232) | Codonics, Inc. | 2004-10-05 |
| ACUMED ANATOMIC RADIAL HEAD SYSTEM (K041858) | Acumed, LLC | 2004-10-05 |
| AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR (K041698) | Axya Medical, Inc. | 2004-10-05 |
| SCANX 14 (K042397) | Air Techniques, Inc. | 2004-10-05 |
| PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS (K042137) | Promedical Products Co., Ltd. | 2004-10-05 |
| ZOLL M SERIES ETC02 LOFLO OPTION (K042417) | Zoll Medical Corp | 2004-10-05 |
| FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS (K042651) | Beckman Coulter, Inc. | 2004-10-05 |
| ADVENTURE A10 (K042535) | Ulrich Alber GmbH | 2004-10-05 |
| NAVIGUS PASSIVE PROBE, MODEL NP-1000 (K040334) | Image-Guided Neurologics, Inc. | 2004-10-04 |
| EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS (K040601) | Exactech, Inc. | 2004-10-04 |
| G-SCAN (K042236) | Esaote, S.p.A. | 2004-10-04 |
| BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR (K033589) | Micromedics, Inc. | 2004-10-04 |
| ENDOMETRIAL SAMPLING SYRINGE (K040189) | Rocket Medical Plc | 2004-10-04 |
| PHILIPS IU22 ULTRASOUND SYSTEM (K042540) | Philips Ultrasound, Inc. | 2004-10-04 |
| PRACTIX CONVENIO (K042368) | Philips Medical Systems North America Co. | 2004-10-04 |
| PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606 (K041919) | Clinico | 2004-10-04 |
| PRECISION LIQUID OXYGEN SYSTEM (K041122) | Precision Medical, Inc. | 2004-10-04 |
| BP-SPECT V1.O (K042258) | Syntermed, Inc. | 2004-10-04 |
| MICROALBUMIN MULTI-CALIBRATOR SET (K042243) | Diagnostic Chemicals , Ltd. | 2004-10-04 |
| VARICES NEEDLE (K031238) | Scandimed. A.S. | 2004-10-04 |
| HDS INTRA-ORAL IMAGING SYSTEM (K042372) | Vatech Value Added Technology Co., Ltd. | 2004-10-04 |
| CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION (K042525) | Ge Medical Systems Information Technologies | 2004-10-01 |
| POWERED WHEELCHAIR, MODEL C-1000 (K041211) | Otto Bock Healthcare LP | 2004-10-01 |
| E-PAIN CARE (K041714) | Breg, Inc. | 2004-10-01 |
| SYNTHES CONTOURED SYNMESH SPACER (K041389) | Synthes Spine | 2004-10-01 |
| POWERED WHEELCHAIR, MODEL B-600 (K041210) | Otto Bock Healthcare LP | 2004-10-01 |
| EXACTECH OPTETRAK UNICONDYLAR KNEE (K040889) | Exactech, Inc. | 2004-10-01 |
| M2A MAGNUM SYSTEM (K042037) | Biomet, Inc. | 2004-10-01 |
| INTRAUTERINE VENOGRAM NEEDLE SET (K041062) | Cook Urological, Inc. | 2004-10-01 |
| HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 (K042070) | Medtronic Vascular | 2004-10-01 |
| MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM (K042402) | Medtronic Sofamor Danek, Inc. | 2004-10-01 |
| LSO PET/CT HIREZ 64 (K042467) | Cti Pet Systems, Inc. | 2004-10-01 |
| SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-331 (K040311) | Shian Jia Meei Enterprise Co., Ltd. | 2004-10-01 |
| KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM (K042503) | Heinz Kurz GmbH Medizintechnik | 2004-10-01 |
| ZILVER 518 BILIARY STENT (K042518) | Cook, Inc. | 2004-10-01 |
| POWERED WHEELCHAIR, MODEL B-500 (K041208) | Otto Bock Healthcare LP | 2004-10-01 |
| MENTAMOVE (K040849) | Cole & Associates | 2004-10-01 |
| XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605 (K041962) | Abbott Laboratories | 2004-10-01 |
| ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM (K041808) | Endius, Inc. | 2004-10-01 |
| TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ (K040630) | Implex Corp. | 2004-09-30 |
| V-CORE FULL CORE BREAST BIOPSY INSTRUMENT (K042464) | Medical Device Technologies, Inc. | 2004-09-30 |
| INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP (K042267) | Inovel, LLC | 2004-09-30 |
| STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM (K041651) | Stryker Leibinger | 2004-09-30 |
| ERCHONIA EML LASER (K041139) | Erchonia Medical, Inc. | 2004-09-30 |
| DELFIA NEONATAL 17A-OH-PROGESTERONE KIT (K042424) | Wallac OY | 2004-09-30 |
| AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (K042425) | Wallac OY | 2004-09-30 |
| PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE (K042062) | Bard Peripheral Vascular, Inc. | 2004-09-30 |
| COOLCUBE COOLPEN (K041767) | Bruce J. Sand M.D. | 2004-09-30 |
| SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY (K042226) | Syntex Healthcare Products Co., Ltd. | 2004-09-30 |
| ELECSYS FOLATE II CALSET II (K042490) | Roche Diagnostics Corp. | 2004-09-30 |
| PERIFIX CATHETER AND CONTIPLEX CATHETER (K042488) | B.Braun Medical, Inc. | 2004-09-30 |
| AMPLIFE DIGITAL CLINICAL THERMOMETER (K042575) | Amplife Corporation | 2004-09-30 |
| SHOULDER FIXATION SYSTEM (K042059) | Hand Innovations, Inc. | 2004-09-30 |
| PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES (K042364) | Lamont Medical, Inc. | 2004-09-30 |
| WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM (K042065) | Boston Scientific Corp | 2004-09-30 |
| AZ ULTRASONIC SYSTEM (K042056) | J. Morita USA, Inc. | 2004-09-30 |
| BARDEX I.C. LATEX FOLEY CATHETER (K040658) | C.R. Bard, Inc. | 2004-09-29 |
| P4-FITNESS (K031611) | Valmed Corp. | 2004-09-29 |
| MAGELLAN RATIO DISPENSER KIT (K041830) | Medtronic Perfusion Systems | 2004-09-29 |
| 8600 VITAL SIGNS MONITOR (K042569) | Criticare Systems, Inc. | 2004-09-29 |
| THE STRIPPER PGD (K041435) | Mid-Atlantic Diagnostics, Inc. | 2004-09-29 |
| ARION (K042474) | Wavelight Laser Technologie AG | 2004-09-29 |
| ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) (K041866) | Axis-Shield Diagnostics, Ltd. | 2004-09-29 |
| HOVEROUND POWER WHEELCHAIR, MODEL HD700 (K042033) | Hoveround Corp. | 2004-09-29 |
| ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE (K042015) | Bayer Healthcare, Diagnostics Division | 2004-09-29 |
| SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM (K042277) | Integra Neurosciences, Ltd. | 2004-09-29 |
| EDWARDS E360 SURGICAL ABLATION DEVICE (K041739) | Edwards Lifesciences, LLC | 2004-09-29 |
| DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D (K042361) | Sedecal USA, Inc. | 2004-09-29 |
| COMPASS M10 SYSTEM (K041724) | Medcare Flaga | 2004-09-28 |
| GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103 (K041079) | Guan Hong Enterprise Co., Ltd. | 2004-09-28 |
| PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE (K042233) | Depuy Mitek, A Johnson & Johnson Company | 2004-09-28 |
| ENDOTINE MIDFACE B 4.5 DEVICE (K041835) | Coapt Systems, Inc. | 2004-09-28 |
| COSMED PONY FX (K040549) | Cosmed Srl | 2004-09-28 |
| POLAR WAND (K041783) | Chek-Med Systems | 2004-09-28 |
| LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # LS1500 (K041587) | Valleylab | 2004-09-28 |
| VALUPEN,PROFILE (K041868) | Conmed Corporation | 2004-09-28 |
| POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE (K042141) | Teleflex Medical | 2004-09-28 |
| HEMOSIL CALIBRATION PLASMA (K041905) | Instrumentation Laboratory CO | 2004-09-28 |
| COOLTOUCH, MODEL NS 160 (K040921) | Cooltouch, Inc. | 2004-09-28 |
| FLO-ASSISTANT (K041560) | Northgate Technologies, Inc. | 2004-09-28 |
| VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS (K042303) | Ortho-Clinical Diagnostics | 2004-09-27 |