| NEXIVA CLOSED IV CATHETER SYSTEM (K032843) | Becton Dickinson Infusion Therapy Systems, Inc. | 2004-02-27 |
| EXACTECH RESORBABLE BONE PASTE (K020078) | Exactech, Inc. | 2004-02-27 |
| LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM (K040409) | Larsen & Toubro Limited | 2004-02-27 |
| VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 (K033879) | Maine Standards Co. | 2004-02-27 |
| LYPHOCHEK HEMOSTASIS CONTROL (K040275) | Bio-Rad | 2004-02-27 |
| CONDUCTIVITY/TDS CALIBRATOR SOLUTION (K033330) | Mesa Laboratories, Inc. | 2004-02-27 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE (K040006) | Becton, Dickinson & CO | 2004-02-27 |
| AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE (K032421) | Ambu, Inc. | 2004-02-27 |
| POWER LED (K033697) | Dental Products of USA, Inc. | 2004-02-27 |
| LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA (K033786) | Ibl GmbH | 2004-02-27 |
| RANDOX URIC ACID (K033278) | Randox Laboratories, Ltd. | 2004-02-27 |
| CENTRAL STATION, VERSION 3.3H (K040032) | Hommed, LLC | 2004-02-27 |
| TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING (K040129) | Wilson-Cook Medical, Inc. | 2004-02-27 |
| BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR (K033771) | Bio-Detek, Inc. | 2004-02-27 |
| POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB (K031097) | Sophysa SA | 2004-02-26 |
| DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER (K040184) | Cobe Cardiovascular, Inc. | 2004-02-26 |
| 3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316 (K032555) | Totoku Electric Co., Ltd. | 2004-02-26 |
| NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES WITH ALOE (K033086) | Pt. Medisafe Technologies | 2004-02-26 |
| MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM (K040201) | Integra Neurosciences Implants S.A. | 2004-02-26 |
| COOK FIVE LUMEN CENTRAL VENOUS CATHETER (K032274) | Cook, Inc. | 2004-02-26 |
| PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY (K033479) | Remel, Inc. | 2004-02-26 |
| ORTHODONTIC COMPOSITE BRACKET SYSTEM (K032625) | Ultradent Products, Inc. | 2004-02-26 |
| CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT (K040252) | Rex Medical | 2004-02-26 |
| EPICOR MEDICAL ABLATION SYSTEM (K022894) | Epicor Medical, Inc. | 2004-02-26 |
| ENVOY PATIENT MONITOR (K030722) | Mennen Medical, Inc. | 2004-02-26 |
| OSSTELL MENTOR RFA (K033689) | Integration Diagnostics, Ltd. | 2004-02-26 |
| MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K040214) | Masimo Corp. | 2004-02-25 |
| ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM (K033053) | Alveolus, Inc. | 2004-02-25 |
| MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN) (K033940) | Dade Behring, Inc. | 2004-02-25 |
| TRANSET FRACTURE FIXATION SYSTEM (K033717) | Bonutti Research, Inc. | 2004-02-25 |
| AUTOQUANT PLUS (K040326) | Adac Laboratories | 2004-02-25 |
| GOLDWAY UT4000A VITAL SIGNS MONITOR (K033988) | Goldway (Us), Inc. | 2004-02-25 |
| LIGHT AGE Q-CLEAR LASER, MODEL 701-1101 (K033259) | Light Age, Inc. | 2004-02-25 |
| CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1 (K033395) | Codman & Shurtleff, Inc. | 2004-02-25 |
| COLORADO MICRODISSECTION NEEDLE (K033232) | Stryker Corp. | 2004-02-25 |
| SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975 (K033981) | Smith & Nephew, Inc. | 2004-02-25 |
| BISX (K040183) | Aspect Medical Systems, Inc. | 2004-02-25 |
| ELECSYS C-PEPTIDE CALCHECK (K040157) | Roche Diagnostics Corp. | 2004-02-25 |
| VERTEBRON PSS PEDICLE SCREW SYSTEM (K033352) | Vertebron, Inc. | 2004-02-25 |
| ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER (K033650) | Siemens Medical Solutions USA, Inc. | 2004-02-24 |
| DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES (K033723) | Baoding Guanzhong Glove Co., Ltd. | 2004-02-24 |
| DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862 (K040309) | Nihon Seimitsu Sokki Co., Ltd. | 2004-02-24 |
| COBRA SURGICAL PROBE (K040219) | Boston Scientific Corp | 2004-02-24 |
| VITREA2 VERSION 3.5 (K040305) | Vital Images, Inc. | 2004-02-24 |
| CALYSTO SERIES IV PATIENT CARE MONITORS AND CENTRAL STATION AND ECG MANAGEMENT SYSTEM (K033030) | Witt Biomedical Corp | 2004-02-24 |
| HERMES (K033996) | 3M Espe AG Dental Products | 2004-02-24 |
| DUAL TOP ANCHOR SYSTEM SCREWS (K033767) | Jeil Medical Corporation | 2004-02-24 |
| SKINTACT ECG ELECTRODE (K040249) | Leonhard Lang GmbH | 2004-02-24 |
| POWDER FREE LATEX SURGEONS GLOVES POLYMER COATED STERILE WITH OPTIONAL LABELING CLAIM OF E.P. LESS THAN 50 UG/DM2 (K033564) | Kanam Latex Industries Pvt. , Ltd. | 2004-02-24 |
| CREATION NM DIAGNOSTIC CATHETERS (K032888) | Neich Medical (Shenzhen) Company Limited | 2004-02-24 |
| MAXTER POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES (K040176) | Maxter Glove Manufacturing Sdn Bhd | 2004-02-24 |
| DEPUY SIGMA XLK TIBIAL INSERTS (K040166) | DePuy Orthopaedics, Inc. | 2004-02-23 |
| SIROAIR L AIR SCALER (K033812) | Sirona Dental Systems GmbH | 2004-02-23 |
| SYNTHES (USA) CRANIOFACIAL PLATES (K040272) | Synthes (Usa) | 2004-02-23 |
| TITANIUM CANNULATED INTERFERENCE SCREW (K033749) | Advanced Biomaterials | 2004-02-23 |
| LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS (K040091) | Cliniqa Corporation | 2004-02-23 |
| MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1 (K033820) | Microlife Intellectual Property GmbH | 2004-02-23 |
| NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236 (K033724) | Nobel Biocare Uas, Inc. | 2004-02-23 |
| SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038 (K033678) | Spectranetics Corp. | 2004-02-23 |
| ACE PROXIMAL HUMERAL NAIL SYSTEM (K033806) | Depuy Ace | 2004-02-20 |
| INFRARED SCIENCES BREASTSCAN IR SYSTEM (K032350) | Infrared Sciences Corp. | 2004-02-20 |
| THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEM (K032064) | Theken Surgical,Llc | 2004-02-20 |
| SMARTEP-ASSR, MODEL M811007 (K031051) | Intelligent Hearing Systems | 2004-02-20 |
| PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER (K033676) | Kendall | 2004-02-20 |
| SINON POWER WHEELCHAIR, SN-W401 (K040319) | Sinon Corporation | 2004-02-20 |
| DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D (K033809) | Dade Behring, Inc. | 2004-02-20 |
| MAMMOTOME EX HAND HELD SYSTEM (K033700) | Ethicon Endo-Surgery, Inc. | 2004-02-20 |
| COLOR LCD DISPLAY, MODEL RADIFORCE R22 (K033466) | Eizo Nanao Corporation | 2004-02-20 |
| PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T (K032979) | Philips Medical Systems, Inc. | 2004-02-20 |
| EARLOOP PROCEDURE MASK (K034015) | Medipack Medical Packaging Mfg. Co. | 2004-02-20 |
| HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES (K031774) | Westcon Contact Lens Co., Inc. | 2004-02-20 |
| BRAIN PERFUSION OPTION (K033677) | Philips Medical Systems (Cleveland), Inc. | 2004-02-20 |
| DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE (K032443) | Shimadzu Corp. | 2004-02-20 |
| KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY (K033821) | Eastman Kodak Company | 2004-02-20 |
| TROPHYPAN AND TROPHYPAN C (K033690) | Trophy Radiologie | 2004-02-20 |
| DORC VITRECTOMY LENSES, MODEL 1284 SERIES (K033950) | Dutch Ophthalmic Research Center (D.O.R.C.) | 2004-02-20 |
| STRYKER SPINE OASYS SYSTEM (K032394) | Howmedica Osteonics Corp. | 2004-02-20 |
| ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM (K033878) | Depuy Ace | 2004-02-20 |
| BILEVEL CPAP, MODEL 9055 SERIES (K032056) | Sunrise Medical | 2004-02-20 |
| PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 (K034054) | Med-Tec,Inc. | 2004-02-20 |
| TRIGEN INTERTAN (K040212) | Smith & Nephew, Inc. | 2004-02-20 |
| AXSYM CORTISOL ASSAY (K033731) | Fujirebio Diagnostics,Inc. | 2004-02-20 |
| HANSSON PIN SYSTEM (K033968) | Howmedica Osteonics Corp. | 2004-02-20 |
| WILSON-COOK USW CAP AND WIRE LOCK (K040137) | Wilson-Cook Medical, Inc. | 2004-02-20 |
| LAD (EPITURE EASYTOUCH), MODEL LAD-08 (K033962) | Norwood Abbey , Ltd. | 2004-02-20 |
| GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587 (K040251) | Ge Med. Systems Ultrasound & Prim. Care Diag.,Llc | 2004-02-20 |
| OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS (K040199) | Osseus, LLC | 2004-02-20 |
| SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES (K033805) | Synthes (Usa) | 2004-02-20 |
| OASIS BILIARY STENT INTRODUCTION SYSTEM (K040151) | Wilson-Cook Medical, Inc. | 2004-02-20 |
| SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E (K040221) | Maquet Critical Care AB | 2004-02-20 |
| MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR (K032551) | Masimo Corp. | 2004-02-19 |
| MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V (K033296) | Masimo Corp. | 2004-02-19 |
| INTEGRIS 3D-RA, RELEASE 4.2 (K040254) | Philips Medical Systems North America Co. | 2004-02-19 |
| GELSOFT PLUS ERS (K034010) | Vascutek, Ltd. | 2004-02-19 |
| C2 NASAL MASK (K033759) | Respironics, Inc. | 2004-02-19 |
| IR FOREHEAD THERMOMETER, MODEL HV-T36 (K032612) | Oriental Inspiration, Ltd. | 2004-02-19 |
| MANOA BREAST BIOPSY SYSTEM (K033205) | Manoa Medical, Inc. | 2004-02-18 |
| SANDMAN SD20 AMPLIFIER (K040113) | Eb Neuro S.P.A. | 2004-02-18 |
| VERTE-STACK SPINAL SYSTEM (K040167) | Medtronic Sofamor Danek | 2004-02-18 |
| SIS PLASTIC SURGERY MATRIX (K034039) | Cook Biotech, Inc. | 2004-02-18 |