| GEN-PROBE APTIMA COMBO 2 ASSAY (K032554) | Gen-Probe, Inc. | 2003-12-31 |
| GORE BIOABSORBABLE MESH (K033671) | W. L. Gore & Associates, Inc. | 2003-12-31 |
| KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS) (K033242) | Imaging Therapeutics, Inc. | 2003-12-31 |
| BIOANCHOR WITH DISPOSABLE DRIVER (K033804) | Linvatec Corp. | 2003-12-31 |
| AMS LARGE PORE POLYPROPYLENE MESH (K033636) | American Medical Systems, Inc. | 2003-12-31 |
| ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY (K033339) | Varian Medical Systems, Inc. | 2003-12-30 |
| MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT (K033778) | C.R. Bard, Inc. | 2003-12-30 |
| TRACER METRO SMART WIRE GUIDE (K033754) | Wilson-Cook Medical, Inc. | 2003-12-30 |
| ULTICARE DISPOSABLE SYRINGE 3 ML/CC (K033794) | Ultimed, Inc. | 2003-12-30 |
| SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 (K033317) | Opus Medical, Inc. | 2003-12-30 |
| VERASOFT ES (K033356) | Aalba Dent, Inc. | 2003-12-30 |
| ATHENA PELVIC MUSCLE TRAINER II (K033256) | Athena Feminine Technologies, Inc. | 2003-12-30 |
| MEDICLUNG, RELEASE 1 (K033412) | Medicsight | 2003-12-30 |
| GRI-BAG, GRI-BAG AP (K033916) | Laboratorios Grifols, S.A. | 2003-12-30 |
| BEBIG ISOSEED I-125 (K033781) | Bebig Isotopen-Und Medizintechnik GmbH | 2003-12-30 |
| CLEARTOOTH DIGITAL X-RAY SYSTEM (K033147) | Cleartooth Electronics, Inc. | 2003-12-30 |
| HYDROCOIL EMBOLIC SYSTEM (HES) (K033836) | MicroVention, Inc. | 2003-12-30 |
| VENUS FLOW (K033665) | Heraeus Kulzer, Inc. | 2003-12-30 |
| HEMEDEX FIXATION DEVICE (K032127) | Hemedex Incorporated | 2003-12-30 |
| EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR (K033250) | Edwards Lifesciences, LLC | 2003-12-30 |
| MYOLIGHT (K033874) | Ge Medical Systems F.I. Haifa | 2003-12-30 |
| GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 (K033038) | Beckman Coulter, Inc. | 2003-12-29 |
| VACUETTE QUICKSHIELD SAFETY TUBE HOLDER (K033478) | Greiner Bio-One Vacuette North America | 2003-12-29 |
| BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100 (K033829) | Bruno Independent Living Aids, Inc. | 2003-12-29 |
| TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS (K032194) | Gen-Probe, Inc. | 2003-12-24 |
| SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES (K031869) | Surgical Instruments Service and Savings, Inc. | 2003-12-24 |
| IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA (K032571) | Immco Diagnostics, Inc. | 2003-12-24 |
| VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS (K033371) | Varian Medical Systems | 2003-12-24 |
| PORTASCAN BLADDER SCANNER, MODEL PA00146 (K033906) | Mediwatch Plc | 2003-12-24 |
| APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4 (K033001) | Transphoton Corporation | 2003-12-24 |
| STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI (K033487) | Dade Behring, Inc. | 2003-12-24 |
| STERICHEK BICARB PH REAGENT STRIPS (K031267) | Environmental Test Systems, Inc. | 2003-12-23 |
| CLINITEST HCG PREGNANCY TEST (K032563) | Bayer Healthcare, LLC | 2003-12-23 |
| IRRIGATION CHANNEL TUBING, MODEL 100135 (K033695) | Byrne Medical, Inc. | 2003-12-23 |
| ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) (K032113) | Chroma Vision Medical Systems, Inc. | 2003-12-23 |
| DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST (K033045) | American Green Dent. Mfg, Inc. | 2003-12-23 |
| ERGO SRS (K031281) | 3D Line USA, Inc. | 2003-12-23 |
| SYNGO PERFUSION-CT (K033832) | Siemens AG Medical Solutions | 2003-12-23 |
| A1CNOW FOR HOME AND PROFESSIONAL USE (K033847) | Metrika, Inc. | 2003-12-23 |
| UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753 (K033113) | Richard Wolf Medical Instruments Corp. | 2003-12-23 |
| INTERMITTENT URETHRAL CATHETERS (K033023) | Rusch Intl. | 2003-12-23 |
| DIAZYME LITHIUM ENZYMATIC ASSAY KIT (K033360) | General Atomics | 2003-12-23 |
| LONG LOVE CONDOM (K033541) | Unidus Corp. | 2003-12-23 |
| SUBTALAR PEG IMPLANT (K033046) | Nexa Orthopedics, Inc. | 2003-12-23 |
| HEPARIN LOCK FLUSH SYRINGE (K032417) | Am2 Pat, Inc. | 2003-12-23 |
| TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200 (K033383) | Biosite Incorporated | 2003-12-23 |
| MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1 (K033712) | Sectra-Imtec AB | 2003-12-23 |
| INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS (K031322) | Intra-Lock International | 2003-12-23 |
| RANDOX EVIDENCE (K030360) | Randox Laboratories, Ltd. | 2003-12-23 |
| DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) (K031689) | Chf Solutions, Inc. | 2003-12-23 |
| DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH (K032061) | Spire Biomedical, Inc. | 2003-12-23 |
| TRILOGY RADIOTHERAPY DELIVERY SYSTEM (K033343) | Varian Medical Systems, Inc. | 2003-12-23 |
| FIDJI LARGE CEMENT RESTRICTOR (K030871) | Spine Next SA | 2003-12-22 |
| VERSYO.BOND (K033629) | Heraeus Kulzer, Inc. | 2003-12-22 |
| RH-950 (K033192) | Iomed, Inc. | 2003-12-22 |
| VINYL EXAMINATION GLOVES, POWDERED (K033308) | Tangshan Transocean Plastic Products Co., Ltd. | 2003-12-22 |
| FIDJI SMALL CEMENT RESTRICTOR (K030767) | Spine Next SA | 2003-12-22 |
| EPRICORD (K033267) | Kuraray Medical, Inc. | 2003-12-22 |
| MESACUP-2 TEST JO-1, MODEL 10756 (K033528) | Rhigene, Inc. | 2003-12-22 |
| CERABIEN ZR (K031968) | Noritake Co., Inc. | 2003-12-22 |
| CLINICAL LASETTE P-200 (K033799) | Cell Robotics, Inc. | 2003-12-22 |
| CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM (K033394) | Cordis Corp. | 2003-12-22 |
| B&R DEVICE (K032925) | Ronvig A/S | 2003-12-22 |
| ALLEGRO IMAGING SYSTEM (K033782) | Philips Medical Systems (Cleveland), Inc. | 2003-12-19 |
| BAY AREA HYPERSCIENCES (K030713) | Bay Area Hypersciences, LLC | 2003-12-19 |
| YA-MAN LASER 21 (K032944) | Ya-Man, Ltd. | 2003-12-19 |
| QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 (K032663) | Instrumentation Laboratory CO | 2003-12-19 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS (K033558) | Becton, Dickinson & CO | 2003-12-19 |
| DEGALL II GALLBLADDER EXTRACTOR (K033359) | Surgicon, Inc. | 2003-12-19 |
| IXL DIABETES MANAGEMENT SYSTEM (K031373) | Insulet Corp. | 2003-12-19 |
| REVOLUTION SPINAL FIXATION SYSTEM (K032219) | Spinal Innovations, Inc. | 2003-12-19 |
| DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM (K033280) | Biomet, Inc. | 2003-12-19 |
| ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT) (K033094) | Lin-Zhi International, Inc. | 2003-12-19 |
| WILSON-COOK TRI-TOME SELECT PLUS (K033203) | Wilson-Cook Medical, Inc. | 2003-12-19 |
| EXACTRAC GATING (K033287) | Brainlab AG | 2003-12-19 |
| SIENET COSMOS (K033831) | Siemens AG Medical Solutions | 2003-12-19 |
| T-TECH DIGITAL, MODEL WL-22XXA SERIES (K033857) | Well-Life Healthcare, Inc. | 2003-12-19 |
| LIFESTYLES LIQUID PERSONAL LUBRICANT (K033076) | Ansell Healthcare, Inc. | 2003-12-19 |
| BAYER CLINITEK STATUS ANALYZER (K031947) | Bayer Healthcare, LLC | 2003-12-19 |
| VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL (K032288) | Orthovita, Inc. | 2003-12-19 |
| GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS (K033867) | General Electric Co. | 2003-12-19 |
| MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V (K033657) | Living Data Technologies Corporation | 2003-12-19 |
| MEDISCOPE (K031436) | Sometech Corporation | 2003-12-19 |
| PLASMACURE BXE (K033795) | Eele Laboratories, LLC | 2003-12-19 |
| SAFYRE VS AND SAFYRE T (K033691) | Promedon | 2003-12-19 |
| INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 (K033603) | Beckman Coulter, Inc. | 2003-12-19 |
| IMMUNETECH TOTAL IGE SYSTEM (K032251) | Immunetech Corporation | 2003-12-19 |
| WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER (K033084) | Portex , Ltd. | 2003-12-19 |
| VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER (K032763) | Vascular Solutions, Inc. | 2003-12-19 |
| PHENOL RED STOCK SOLUTION (K032887) | Irvine Scientific Sales Co., Inc. | 2003-12-19 |
| SHELHIGH NO-REACT BIOCUFF (K032893) | Shelhigh, Inc. | 2003-12-19 |
| HYDROPHILIC GUIDEWIRE (K033758) | Lake Region Mfg., Inc. | 2003-12-19 |
| FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 (K031260) | Abbott Diabetes Care, Inc. | 2003-12-19 |
| GEM INSET PATELLAR COMPONENT (K032950) | Kinamed, Inc. | 2003-12-19 |
| BAYER SPECIAL CHEMISTRY CONTROLS (K033379) | Bayer Diagnostics Corp. | 2003-12-19 |
| INSTAREAD LITHIUM SYSTEM (K031579) | Akers Laboratories, Inc. | 2003-12-19 |
| LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01, 2003-05, 2004-01, 2004-05, 2005-01, 2005-05 (K033159) | LeMaitre Vascular, Inc. | 2003-12-19 |
| TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM (K031831) | Topcon Medical Systems, Inc. | 2003-12-19 |
| MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1 (K032928) | Mediphysics Pain Centers of America | 2003-12-19 |
| IMPAK ACRYLIC REPAIR RESIN LIQUID (K033020) | Cmp Industries, LLC | 2003-12-19 |