| PHILIPS EASYDIAGNOST ELEVA (K031535) | Philips Medical Systems North America Co. | 2003-06-17 |
| RUSCH GUIDED CHOLANGIOGRAPHY CATHETER (K023666) | Rusch Intl. | 2003-06-17 |
| MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G (K031384) | Yty Industry (Manjung) Sdn Bhd | 2003-06-17 |
| MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER (K030531) | Minimed, Inc. | 2003-06-17 |
| ONE-STEP PREGNANCY TEST (K031271) | Amerisource Pharmacal, Inc. | 2003-06-17 |
| SKYLIGHT IMAGING SYSTEM (K031705) | Adac Laboratories | 2003-06-17 |
| URINARY CATHETERS (K031409) | Promedic, Inc. | 2003-06-17 |
| TENS PRO 900 (K023726) | Acumed Medical Supplies , Ltd. | 2003-06-17 |
| BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 (K030099) | Baxter Healthcare Corp | 2003-06-17 |
| LORENZE EXTERNAL MANDIBULAR DISTRACTOR (K031696) | Walter Lorenz Surgical, Inc. | 2003-06-17 |
| IMAGINE REFLEX (K031326) | Wieland Dental + Technik GmbH & Co. KG | 2003-06-17 |
| ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) (K030528) | Clinical Data | 2003-06-17 |
| VMATE MODEL VMM1000 (K030948) | Howard Instruments, Inc. | 2003-06-17 |
| SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK (K030891) | Surgistar, Inc. | 2003-06-17 |
| ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE (DEN030002) | Spectral Diagnostics, Inc. | 2003-06-16 |
| MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (K031197) | Cordis Corp. | 2003-06-16 |
| VIDAS TROPONIN I (TNI), MODEL 30 445 (K030950) | bioMerieux, Inc. | 2003-06-16 |
| CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST (K031048) | Access Bio Incorporate | 2003-06-16 |
| RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 (K031101) | Hemagen Diagnostics, Inc. | 2003-06-16 |
| MODIFICATION TO IVS INTRODUCER SET, MODEL 1003 (K031583) | Integrated Vascular Systems, Inc. | 2003-06-16 |
| HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER (K030020) | C.R. Bard, Inc. | 2003-06-16 |
| LEKTROGEL, MODEL LK3001 (K030887) | Inmed Ltda. | 2003-06-13 |
| FINAL VARNISH LC (K030844) | Voco GmbH | 2003-06-13 |
| PROFILE 1064 LASER SYSTEM (K023881) | Sciton, Inc | 2003-06-13 |
| CORD STICK MULTIPLE DRAW SYSTEM (K031058) | Cord Stick Corp. | 2003-06-13 |
| PASCO MIC AND MIC/ID PANELS (K031205) | Pasco Laboratories, Inc. | 2003-06-13 |
| VANTAGE ANTERIOR FIXATION SYSTEM (K031533) | Medtronic Sofamor Danek, Inc. | 2003-06-13 |
| CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE (K031021) | Perusahaan Getah Asas Sdn. Bhd. | 2003-06-13 |
| CARESTART HCG ONE-STEP PREGNANCY TEST (K031052) | Access Bio Incorporate | 2003-06-13 |
| RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 (K030211) | Icn Biomedicals, Inc. | 2003-06-13 |
| NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR/APPLE/PEPPERMINT SCENTS (K030993) | Sgmp Co., Ltd. | 2003-06-12 |
| OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 (K031083) | Opus Medical, Inc. | 2003-06-12 |
| NON-STERILE ORANGE COLORED POWDERED LATEX PATINET EXAMINATION GLOVES WITH & WITHOUT ORANGE/VANILLA SCENTS (K030994) | Sgmp Co., Ltd. | 2003-06-12 |
| SINGLE USE ORAL MASK, MODEL HC455A (K023670) | Fisher & Paykel Healthcare, Ltd. | 2003-06-12 |
| HA PMI FLANGED ACETABULAR COMPONENT (K030861) | Biomet, Inc. | 2003-06-12 |
| OTI BONE CEMENT PLUG (K030608) | Osteoimplant Technology, Inc. | 2003-06-12 |
| BLACKSTONE POSTERIOR CERVICAL SYSTEM (K030197) | Blackstone Medical, Inc. | 2003-06-12 |
| PASCO MIC AND MIC/ID PANELS (ERTAPENEM) (K031103) | Pasco Laboratories, Inc. | 2003-06-12 |
| FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK (K023559) | Fisher & Paykel Healthcare, Ltd. | 2003-06-12 |
| CONTACT LENS STORAGE CASE (K030987) | Pelican Products | 2003-06-12 |
| PORTA PRESSOVER (K031264) | Wieland Dental + Technik GmbH & Co. KG | 2003-06-12 |
| PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS (K031495) | DePuy Orthopaedics, Inc. | 2003-06-11 |
| IQMARK DIGITAL HOLTER (K031466) | Brentwood Medical Technology Corp. | 2003-06-11 |
| ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES (K030800) | Eletromed, Inc. | 2003-06-11 |
| EKGCARD SYSTEM (K030535) | Qrs Diagnostic, LLC | 2003-06-11 |
| VECTORVISION FLUORO3D (K024192) | Brainlab AG | 2003-06-11 |
| NANO-TICROWN (K031627) | Nano-Write Corp. | 2003-06-11 |
| GALIX PACESTAR (K023080) | Galix Biomedical Instrumentation, Inc. | 2003-06-11 |
| PRIME ECG SYSTEM (K030104) | Meridian Medical Technologies, Inc. | 2003-06-11 |
| RESQPOD CIRCULATORY ENHANCER (K022906) | Cprx, LLC | 2003-06-11 |
| DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER (K024010) | The Kendall Company Div. of Tyco Healthcare Group | 2003-06-11 |
| CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C (K031633) | Canon USA, Inc. | 2003-06-11 |
| DISPOSABLE TEMPORARY PACING WIRE (K023174) | River Medical, Inc. | 2003-06-11 |
| POWDERED VINYL EXAM GLOVES, WHITE (K031104) | Glormed Intl., Inc. | 2003-06-10 |
| CONTEC LIGHT (K030641) | Dentaurum | 2003-06-10 |
| COOL CURE (K030811) | Samm, Inc. | 2003-06-10 |
| SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000 (K021360) | Med-Tec,Inc. | 2003-06-10 |
| WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS (K030519) | Hand Biomechanics Lab, Inc. | 2003-06-10 |
| WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELD (K023755) | Winner Industries (Shenzhen) Co., Ltd. | 2003-06-10 |
| INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST (K024360) | Alfa Scientific Designs, Inc. | 2003-06-10 |
| HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY (K031348) | Salimetrics, LLC | 2003-06-10 |
| KLINIDRAPE SURGICAL DRAPES (K031131) | Molnlycke Health Care | 2003-06-10 |
| DISPOSABLE POWDER FREE VINYL EXAM GLOVES (K031113) | Elite International, Inc. | 2003-06-10 |
| ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED (K024111) | Astra Tech, Inc. | 2003-06-10 |
| DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX (K031569) | Datascope Corp. | 2003-06-10 |
| HOBBS MISTIFIER SPRAY CATHETER (K030765) | Hobbs Medical, Inc. | 2003-06-09 |
| KAISHOU VAGINAL SPECULUM (K030761) | Jiangsu Kaishou Medical Apparatus Co., Ltd. | 2003-06-09 |
| READI-STRAND, MODEL PSSTRAND (K022705) | Worldwide Medical Technologies, LLC | 2003-06-09 |
| SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM (K031609) | Swiss Orthopedic Solutions, Inc. | 2003-06-09 |
| GE VIVID 7, MODEL FC0003XX (K031663) | General Electric Co. | 2003-06-09 |
| CARIES INDICATOR (K030807) | Confi-Dental Products Co. | 2003-06-09 |
| WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET (K024280) | Wako Chemicals USA, Inc. | 2003-06-06 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML (K031429) | Bd Diagnostic Systems | 2003-06-06 |
| MEDELA PUMP IN STYLE ADVANCED BREAST PUMP (K031614) | Medela, Inc. | 2003-06-06 |
| SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM (K030738) | Siemens Medical Solutions USA, Inc. | 2003-06-06 |
| SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE (K031573) | Synthes (Usa) | 2003-06-06 |
| CONTROL PLASMA LMW HEPARIN (K030965) | Instrumentation Laboratory CO | 2003-06-06 |
| PRESSURE WIRE SENSOR, MODELS 12004/12304 (K031662) | Radi Medical Systems AB | 2003-06-06 |
| CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI (K031629) | Canon USA, Inc. | 2003-06-06 |
| TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P (K030951) | Bisco, Inc. | 2003-06-06 |
| GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100 (K022926) | Genteel Technology Co., Ltd. | 2003-06-06 |
| AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506 (K031479) | Datex-Ohmeda, Inc. | 2003-06-06 |
| MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 (K030332) | Bionicare Medical Technologies, Inc. | 2003-06-06 |
| CUFFLOK ANCHOR (K031519) | Mitek Worldwide | 2003-06-06 |
| PLUS ORTHOPEDICS CEMENTED HIP STEM (K031165) | Plus Orthopedics | 2003-06-06 |
| BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY (K031594) | M.K. Meditech Co. , Ltd. | 2003-06-06 |
| CALIBRATION PLASMA LMW HEPARIN (K030964) | Instrumentation Laboratory CO | 2003-06-06 |
| MSD CABLE REDUCTION SYSTEM (K030816) | Medtronic Sofamor Danek | 2003-06-06 |
| ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP (K030842) | Soflex Contact Lens Industries , Ltd. | 2003-06-06 |
| SYVA EMIT II PLUS AMPHETAMINES ASSAY (K031004) | Dade Behring, Inc. | 2003-06-06 |
| PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US (K031470) | Tyco Healthcare Nancy | 2003-06-05 |
| POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT (K030727) | Healex Products, Inc. | 2003-06-05 |
| EZMANAGER PLUS (K022394) | Animas Corp. | 2003-06-05 |
| C-PORT (K030636) | Clinisurg Vascular Products, LLC | 2003-06-05 |
| MODIFICATION TO CAVERMAP SURGICAL AID (K031527) | Blue Torch Medical Technologies | 2003-06-05 |
| POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM (K030445) | Primus Gloves Private , Ltd. | 2003-06-05 |
| MERDOC SYSTEM (K022393) | Stryker Endoscopy | 2003-06-05 |
| PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES (K030444) | Primus Gloves Private , Ltd. | 2003-06-05 |
| SCB COMPUTER MOTION INTERFACE CONTROLLER (K030718) | Computer Motion, Inc. | 2003-06-05 |
| SHELHIGH BIORING (K023940) | Shelhigh, Inc. | 2003-06-04 |