| INOVO, INC, ECONOMIZER CONSERVING REGULATOR (K031983) | Inovo, Inc. | 2003-09-15 |
| PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP) (K032518) | Bd Diagnostic Systems | 2003-09-15 |
| RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE (K032054) | Radionics, A Division of Tyco Healthcare Group LP | 2003-09-15 |
| ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00, (K031972) | Asap Endoscopic Products GmbH | 2003-09-15 |
| SALINUM, ORCLAIR (K024148) | Sinclair Pharmaceuticals, Ltd. | 2003-09-15 |
| KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A (K032212) | Kyphon, Inc. | 2003-09-15 |
| FLUORIDE VARNISH (K031932) | Dentsply Intl. | 2003-09-15 |
| DURACON TOTAL KNEE SYSTEM (K032163) | Howmedica Osteonics Corp. | 2003-09-12 |
| SAFETY-MULTIFLY (K032150) | Sarstedt, Inc. | 2003-09-12 |
| THERMOSKIN CONDUCTIVE PADS (K030564) | United Pacific, Inc. | 2003-09-12 |
| HANDYDOP (K030466) | Elcat, GmbH | 2003-09-12 |
| AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION (K030522) | Ciba Vision Corporation | 2003-09-12 |
| E275 (K032653) | Micro Current Technology, Inc. | 2003-09-12 |
| POLESTAR N-20 (K032541) | Odin Medical Technologies , Ltd. | 2003-09-12 |
| 3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL (K032618) | Usa Instruments, Inc. | 2003-09-12 |
| RS-4I MUSCLE STIMULATOR FAMILY (K032652) | Rs Medical | 2003-09-12 |
| ACCU-CHEK ADVANTAGE SYSTEM (K032552) | Roche Diagnostics Corp. | 2003-09-12 |
| CD HORIZON SPINAL SYSTEM (K032033) | Medtronic Sofamor Danek | 2003-09-12 |
| VORTEX MP (K032754) | Horizon Medical Products, Inc. | 2003-09-12 |
| MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 (K030961) | Microlife Corp. | 2003-09-12 |
| QUANTUM WARP 10 LIGHT DELIVERY SYSTEM (K032229) | Quantum Devices, Inc. | 2003-09-12 |
| MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM) (K032588) | Disco-O-Tech Medical Technologies, Ltd. | 2003-09-12 |
| INDUCTION AND SAMPLING MANIFOLD (OR STOPCOCK) (K032393) | Elcam Medical Acal | 2003-09-12 |
| 3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL (K032538) | Usa Instruments, Inc. | 2003-09-12 |
| S-MONOVETTE EDTA K2-GEL (K031359) | Sarstedt, Inc. | 2003-09-12 |
| TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 (K031951) | Baylis Medical Co., Inc. | 2003-09-11 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML (K032153) | Bd Diagnostic Systems | 2003-09-11 |
| COMPOSITE RESTORATION MATERIAL (K031721) | Milton Hodosh, M.D. | 2003-09-11 |
| DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY (K032638) | Planar Systems, Inc. | 2003-09-11 |
| DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING (K032418) | Howmedica Osteonics Corp. | 2003-09-11 |
| PANTOS, MODELS: PANTOS 16, AND PANTOS DG (K031801) | Blue X Imaging Srl | 2003-09-11 |
| QUICKVUE INFLUENZA A+B TEST (K031899) | Quidel Corp. | 2003-09-11 |
| FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM (K032640) | U-Systems, Inc. | 2003-09-11 |
| RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR (K032561) | Medtronic Vascular | 2003-09-11 |
| MICROLIFE MODEL MT18E1-1 (V932-1) DIGITAL UNDERARM ELECTRONIC THERMOMETER (K032658) | Microlife Intellectual Property GmbH | 2003-09-11 |
| LATEX ULTRASONIC PROBE COVER (K022156) | Pleasure Latex Products Sdn. Bhd. | 2003-09-11 |
| SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM (K031985) | Spinal Concepts, Inc. | 2003-09-11 |
| B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM (K022258) | B.T.I. Biotechnology Institute, Sl. | 2003-09-11 |
| STERI-DRAPE SURGICAL DRAPES (K031287) | 3M Company | 2003-09-10 |
| BINDAZYME CLQ CIC EIA KIT (K031563) | The Binding Site, Ltd. | 2003-09-10 |
| WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022) (K032271) | Wartner USA B.V. | 2003-09-10 |
| OSTEOMED ALVEOLAR DISTRACTION SYSTEM (K030790) | Osteomed LP | 2003-09-10 |
| MICRUS MICROCATHETER (K032624) | Micrus Corp. | 2003-09-10 |
| VITEK 2 GRAM POSITIVE MOXIFLOXACIN (K032399) | bioMerieux, Inc. | 2003-09-10 |
| SIREMOBIL ISO-C 3D (K032280) | Siemens AG | 2003-09-10 |
| TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT (K032134) | Kronus Market Development Associates, Inc. | 2003-09-10 |
| SELDINGER SAFETY NEEDLE INTRODUCER (K032404) | Hdc Corp. | 2003-09-10 |
| SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS: (K031800) | Solarc Systems, Inc. | 2003-09-10 |
| UNIVERSAL NEURO SYSTEM (K031659) | Stryker Instruments | 2003-09-10 |
| PATHWAY ACCESS SHEATH CATHETER (K030734) | Vertelink Corporation | 2003-09-10 |
| INTERA-SENSATION FAMILY (K031815) | Philips Medical Systems | 2003-09-10 |
| MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM (K032535) | Roche Diagnostics Corp. | 2003-09-10 |
| IP-XS COMPRESSION NAIL SYSTEM (K032548) | Plus Orthopedics | 2003-09-10 |
| INFINITY MEGACARE (K031970) | Siemens Medical Solutions USA, Inc. | 2003-09-09 |
| AMPLATZER VASCULAR PLUG (K031810) | Aga Medical Corp. | 2003-09-09 |
| BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER (K032525) | Bayer Healthcare, LLC | 2003-09-09 |
| VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233 (K032600) | Boston Scientific Corp | 2003-09-09 |
| PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15 (K022752) | Hdc Corp. | 2003-09-09 |
| TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER (K032238) | Neurosel (Medical) Limited | 2003-09-09 |
| SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX (K031849) | Datascope Corp. | 2003-09-09 |
| IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA (K030701) | Immco Diagnostics, Inc. | 2003-09-09 |
| AUDIT MICROCONTROLS MICROFD BNP CONTROL (K032122) | Aalto Scientific, Ltd. | 2003-09-09 |
| BLOOD PRESSURE MONITOR, MODEL KP-7000 (K032492) | K-Jump Health Co., Ltd. | 2003-09-09 |
| RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR (K032149) | Rita Medical Systems, Inc. | 2003-09-09 |
| AXIOM BIOLASER LLLT SERIES-1 (K030622) | Axiom Usa., Inc. | 2003-09-09 |
| IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA (K030702) | Immco Diagnostics, Inc. | 2003-09-09 |
| COMP. E (K032179) | Parkell, Inc. | 2003-09-09 |
| BLU-U, MODEL 4170 (K031805) | Dusa Pharmaceuticals, Inc. | 2003-09-09 |
| MEDLEY PCA MODULE, MODEL 8120 (K032233) | Alaris Medical Systems, Inc. | 2003-09-09 |
| TRIUMPH VTX WITH LIFEVALVE CATHETER (K032557) | Horizon Medical Products, Inc. | 2003-09-09 |
| BD ECLIPSE BIFURCATED NEEDLE (K032528) | Becton, Dickinson & CO | 2003-09-09 |
| ARABELLA NCPAP MASKS (K030563) | Hamilton Medical AG | 2003-09-09 |
| IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER (K032039) | Sysmex America, Inc. | 2003-09-08 |
| DURASIS DURAL SUBSTITUTE (K031850) | Cook Biotech, Inc. | 2003-09-08 |
| MARQUETTE HUBER TRAP SAFETY INFUSION SET (K021471) | Marquette Medical, Inc. | 2003-09-08 |
| SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 (K031377) | Dade Behring, Inc. | 2003-09-08 |
| SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE (K031108) | Shijiazhuang Great Vision Plastic Products Co., LT | 2003-09-08 |
| I-STAT KAOLIN ACT TEST (K023582) | I-Stat Corporation | 2003-09-08 |
| MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES (K032549) | Matang Mfg. Sdn. Bhd. | 2003-09-08 |
| ADVIA 60 HEMATOLOGY ANALYZER (K032524) | Bayer Healthcare, LLC | 2003-09-08 |
| COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E (K023354) | Siemens Elema AB | 2003-09-05 |
| TI FENESTRATED PLATE (K031772) | Interpore Cross Intl. | 2003-09-05 |
| N/T PROTEIN CONTROL (K032237) | Dade Behring, Inc. | 2003-09-05 |
| ENCLOSE II ANASTOMOSIS ASSIST DEVICE (K032589) | Novare Surgical Systems, Inc. | 2003-09-05 |
| ENDOSCOPIC APPLICATOR (K031882) | Baxter Healthcare Corp | 2003-09-05 |
| CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY (K032159) | Access Bio Incorporate | 2003-09-05 |
| ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES (K031764) | Siemens Medical Solutions USA, Inc. | 2003-09-05 |
| CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) (K032027) | Cholestech Corp. | 2003-09-05 |
| ACUEITY MEDICAL LIGHT SOURCE (K032430) | Acueity, Inc. | 2003-09-05 |
| GEL MARK III BIOPSY SITE MARKER (K031938) | Senorx, Inc. | 2003-09-05 |
| ONE DIMENSIONAL WATER PHANTOM, WP 1D (K032594) | Wellhofer Dosimetrie | 2003-09-05 |
| BPCARD (K031964) | Qrs Diagnostic, LLC | 2003-09-05 |
| INTERLOK BIO-MODULAR HUMERAL STEMS (K032507) | Biomet, Inc. | 2003-09-05 |
| BENZODIAZEPINE ENZYME IMMUNOASSAY (K032365) | Lin-Zhi International, Inc. | 2003-09-05 |
| SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE (K031973) | Synthes (Usa) | 2003-09-05 |
| PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 (K032038) | Quinton, Inc. | 2003-09-05 |
| PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER (K032494) | Precision Vascular Systems, Inc. | 2003-09-05 |
| ALANTECH GRAFT FIXATION SCREW (K031937) | Arthrocare Corp. | 2003-09-04 |
| MACROPORE CARDIO-WRAP (TS) (K031785) | Macropore Biosurgery, Inc. | 2003-09-04 |
| SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES (K032032) | Synthes (Usa) | 2003-09-04 |