| SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM (K033618) | Synthes (Usa) | 2004-02-05 |
| AEGIS PIT & FISSURE SEALANT WITH ACP (K033751) | Harry J. Bosworth Co. | 2004-02-05 |
| APEX MEDICAL CPAP RT 21XX (K022650) | Apex Medical Corp. | 2004-02-04 |
| BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM (K032216) | Bioptron AG | 2004-02-04 |
| AMSURE RED RUBBER URETHRAL CATHETER (K030293) | Amsino International, Inc. | 2004-02-04 |
| VARNISHAMERICA (K040098) | Medical Products Laboratories, Inc. | 2004-02-04 |
| THERMAGE THERMACOOL SYSTEM (K033942) | Thermage, Inc. | 2004-02-04 |
| SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29 (K040024) | Power Medical Interventions, Inc. | 2004-02-04 |
| PHOSPHOLIN ES AND CALCIUM CHLORIDE (K033471) | R2 Diagnostics, Inc. | 2004-02-04 |
| BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM (K033497) | C.R. Bard, Inc. | 2004-02-04 |
| BARD TIGERTAIL URETERAL CATHETER (K033719) | C.R. Bard, Inc. | 2004-02-04 |
| MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT (K033652) | Zimmer, Inc. | 2004-02-04 |
| GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES (K033761) | Biocompatibles UK Limited | 2004-02-04 |
| PERIFIX CATHETER CONNECTOR (K033952) | B.Braun Medical, Inc. | 2004-02-04 |
| ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER (K033969) | Vistakon | 2004-02-04 |
| MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE (K033813) | Micrus Corp. | 2004-02-04 |
| POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS (K033706) | Polymedco, Inc. | 2004-02-04 |
| SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 (K033997) | Bacchus Vascular, Inc. | 2004-02-04 |
| HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE (K032969) | Helica Instruments, Ltd. | 2004-02-04 |
| PRESS-MATE BX-10 VITAL SIGN MONITOR (K032857) | Colin Medical Instruments Corp. | 2004-02-04 |
| DURAMAX .018 BILIARY STENT SYSTEM (K032436) | Avantec Vascular Corp. | 2004-02-04 |
| SIMULIX EVOLUTION (K033470) | Nucletron Corporation | 2004-02-04 |
| CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED STAPLER, MODELS CR40B, CR40G (K040038) | Ethicon Endo-Surgery, Inc. | 2004-02-04 |
| INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (K032862) | Interlab S.R.L. | 2004-02-03 |
| MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER (K032593) | Mercury Medical | 2004-02-03 |
| BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 (K033036) | Beckman Coulter, Inc. | 2004-02-03 |
| LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) (K033924) | Bio-Rad Laboratories, Inc. | 2004-02-03 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE (K033889) | Becton, Dickinson & CO | 2004-02-03 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML (K033784) | Becton, Dickinson & CO | 2004-02-03 |
| SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (K033522) | Trek Diagnostic Systems, Inc. | 2004-02-03 |
| CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406 (K033828) | Mick Radio-Nuclear Instruments, Inc. | 2004-02-02 |
| AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 (K030849) | N-Dia, Inc. | 2004-02-02 |
| ORTHOPACS (K033825) | Etrauma.Com Corp. | 2004-02-02 |
| BELIMED STEAM STERILIZER TOP 5000, SERIES 4 - 8 (K033538) | Sauter AG | 2004-02-02 |
| MOBILE COMPACT DIGITAL CARDIAC CAMERA (K040057) | Is2 Research, Inc. | 2004-02-02 |
| AQUIFY MULTI-PURPOSE SOLUTION (K033608) | Ciba Vision Corporation | 2004-02-02 |
| PORTABLE X-RAY UNIT, MODELS PXP-15/20/40HF (K032628) | United Radiology Systems, Inc. | 2004-02-02 |
| GRADIA GUM (K033808) | GC America, Inc. | 2004-02-02 |
| SYNERGY SPINE ARRAY COIL (K033662) | Philips Medical Systems, Inc. | 2004-02-02 |
| MINXRAY, MODEL HF120/60H POWERPLUS (K040046) | Minxray, Inc. | 2004-02-02 |
| CHASE CARDIAC ANALYSIS SYSTEM (K032531) | Chase Medical, Inc. | 2004-02-02 |
| SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE (K033656) | Sauflon Pharmaceuticals, Ltd. | 2004-02-02 |
| STV PRO 2 (K033419) | Trophy Radiologie | 2004-02-02 |
| COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE (K033506) | Biomet, Inc. | 2004-02-02 |
| PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD (K033182) | Surgin Surgical Instrumentation, Inc. | 2004-01-30 |
| ERBE HELIX HYDRO-JET (K033590) | Erbe USA, Inc. | 2004-01-30 |
| MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM (K033757) | Advanced Neuromodulation Systems | 2004-01-30 |
| JOSTRA SUCKERS, MODEL JS (K020983) | Jostra AG | 2004-01-30 |
| OLYMPUS URINE CALIBRATOR (K033910) | Cliniqa Corporation | 2004-01-30 |
| PICCOLO MAGNESIUM TEST SYSTEM (K040115) | Abaxis, Inc. | 2004-01-30 |
| FRESENIUS ULTRAFLO HPX HEMODIALYZER (K034064) | Fresenius Medical Care North America | 2004-01-30 |
| STREET (K032765) | Permobil AB | 2004-01-30 |
| FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER (K033811) | The Binding Site, Ltd. | 2004-01-30 |
| EMORY CARDIAC TOOLBOX VERSION 2.6 (K040141) | Syntermed, Inc. | 2004-01-30 |
| KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS (K033796) | Heinz Kurz GmbH Medizintechnik | 2004-01-30 |
| OLYMPUS VIDEO URETEROSCOPE, NTSC (K033651) | Olympus Winter & Ibe GmbH | 2004-01-30 |
| VADI MANUAL RESUSCITATOR (K030864) | Vedi Corp. | 2004-01-30 |
| CREATININE REAGENT KIT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS (K033058) | Diamond Diagnostics, Inc. | 2004-01-30 |
| UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES (K034022) | Diamodent | 2004-01-30 |
| GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS (K033055) | Diamond Diagnostics, Inc. | 2004-01-30 |
| MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH (K034061) | Boston Scientific Corp | 2004-01-30 |
| WATERLASE (K030523) | Biolase Technology, Inc. | 2004-01-30 |
| CP SLEEVE AND RIVER SLEEVE (K034062) | Cp Medical | 2004-01-30 |
| ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST (K033606) | Axis-Shield Diagnostics, Ltd. | 2004-01-30 |
| BUN REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA REAGENT (K033056) | Diamond Diagnostics, Inc. | 2004-01-30 |
| FLOSENSE II, MODEL 29-8040 (K033939) | Sdi Diagnostics, Inc. | 2004-01-30 |
| ESA PLASMA FREE METANEPHRINE ANALYSIS KIT (K032199) | Esa, Inc. | 2004-01-30 |
| MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM (K030418) | Makai Marine Industries, Inc. | 2004-01-29 |
| HOLOTC RIA (K030655) | Axis-Shield Biochemicals, Asa | 2004-01-29 |
| SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011 (K034058) | Medtronic Vascular | 2004-01-29 |
| MEDONIC CA620/530 HEMATOLOGY ANALYZER (K032214) | Boule Medical AB | 2004-01-29 |
| ABBOTT DATA PORT PC, MODEL 12181 (K040114) | Abbott Laboratories | 2004-01-29 |
| CLEARFIL PROTECT BOND (K033938) | Kuraray Medical, Inc. | 2004-01-29 |
| BD CAREFLOW CENTRAL VENOUS CATHETER (K033500) | Becton, Dickinson & CO | 2004-01-29 |
| SCALETRON PIEZO ULTRASOUND SCALER (K033120) | Pac-Dent International (Suzhou), Ltd. | 2004-01-29 |
| MODIFICATION TO TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST (K032235) | Biosite Incorporated | 2004-01-28 |
| HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX (K031167) | Idt Technology Limited | 2004-01-28 |
| EVOLVE RADIAL PLATE (K033456) | Wrightmedicaltechnologyinc | 2004-01-28 |
| ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES (K033532) | Asia Pacific Latex Sdn Bhd | 2004-01-28 |
| AC-1 SP02 ADAPTOR CABLE, MODEL AC-1 (K033349) | Masimo Corp. | 2004-01-28 |
| ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES (K033530) | Asia Pacific Latex Sdn Bhd | 2004-01-28 |
| SECUMAX BLOOD COLLECTION SYSTEM (K032141) | Tiger Meditech Incorporated | 2004-01-28 |
| RECOM BATTERY-OPERATED AMBULATORY DIGITAL WIRELESS ECG MONITOR, MODEL 100 (K032882) | Recom Managed Systems, Inc. | 2004-01-28 |
| CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376 (K033447) | Mri Devices Corp. | 2004-01-28 |
| SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 (K023713) | Sontra Medical, Inc. | 2004-01-28 |
| SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS (K040060) | Siemens Medical Solutions USA, Inc. | 2004-01-28 |
| 3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR (K032263) | Implant Innovations, Inc. | 2004-01-28 |
| SKY BONE EXPANDER SYSTEM (K034037) | Disc-O-Tech Medical Technologies, Ltd. | 2004-01-28 |
| PLUS PIVOT LINK UNIVERSAL SYSTEM (K033508) | Spine Vision, Inc. | 2004-01-27 |
| AC APPLICATOR, AURORA AC (K032514) | Syneron Medical, Ltd. | 2004-01-27 |
| DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL (K033381) | Discus Dental, Inc. | 2004-01-27 |
| NDI PASSIVE SPHERES (K033621) | Northern Digital, Inc. | 2004-01-27 |
| HEEL SNUGGLER, MODEL 99047 (K040044) | Respironics, Inc. | 2004-01-27 |
| SHIRAZ-JAVA SPINAL FIXATION SYSTEM (K033772) | Spine Next America | 2004-01-27 |
| VIANOX DELIVERY SYSTEM, MODEL II (K033779) | Pulmonox Medical, Inc. | 2004-01-26 |
| PREMIER IMPLANT CEMENT, MODEL 3001450 (K033309) | Premier Dental Products Co. | 2004-01-26 |
| P0RTEX REINFORCED TRACHEAL TUBE (CUFFED AND UNCUFFED) (K032112) | Portex , Ltd. | 2004-01-26 |
| NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 (K033302) | Nichols Institute Diagnostics | 2004-01-26 |
| CARRARA PRESS SYSTEM (K033667) | Dentsply Intl. | 2004-01-23 |
| PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM (K033686) | Smiths Medical MD, Inc. | 2004-01-23 |