| THERMASSAGE ENERGY PRODUCT, MODEL HY5000 (K032449) | Migun Medical Instrument Co. , Ltd. | 2003-10-22 |
| PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM (K032580) | Ev3, Inc. | 2003-10-22 |
| MORALES PROTRACTION FACEMASK (K032392) | Ortosim, S.A. DE C.V. | 2003-10-22 |
| CONKLUSION PEDICLE SCREW SYSTEM (K031455) | Signus Medical, LLC | 2003-10-22 |
| DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) (K031329) | Dynatronics Corp. | 2003-10-22 |
| FERRIS POLYMEM SILVER WOUND DRESSING (K031307) | Ferris Mfg. Corp. | 2003-10-22 |
| INTER-OS LIMB LENGTHENER (K031875) | Inter-Os Technologies | 2003-10-22 |
| MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE (K032420) | ETHICON, Inc. | 2003-10-22 |
| CYNOSURE PHOTOGENICA VL (K032565) | Cynosure, Inc. | 2003-10-22 |
| STS SCREW (K032682) | Ortho-Pro, LLC | 2003-10-22 |
| ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM (K032312) | Medtronic Vascular | 2003-10-21 |
| HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 (K032337) | Hemedex Incorporated | 2003-10-21 |
| S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (K033253) | Micro Current Technology, Inc. | 2003-10-21 |
| BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE (K030348) | Biolab Equipment Canada , Ltd. | 2003-10-21 |
| ISO-ELASTIC CERCLAGE SYSTEM (K030256) | Kinamed, Inc. | 2003-10-21 |
| COMBI-SCREEN, MODELS 10SL AND 11SL (K023885) | Analyticon Biotechnologies AG | 2003-10-21 |
| GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM (K032985) | Hmd Biomedical, Inc. | 2003-10-21 |
| BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 (K032166) | Binax, Inc. | 2003-10-21 |
| GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER (K032608) | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | 2003-10-21 |
| LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS (K032074) | Cliniqa Corporation | 2003-10-21 |
| MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI (K032465) | Satelec | 2003-10-21 |
| GE LOGIQ 5 PRO OR EXPERT (K032974) | General Electric Co. | 2003-10-21 |
| THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT (K032351) | BioHorizons Implant Systems, Inc. | 2003-10-21 |
| NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE (K032917) | Orthosoft, Inc. | 2003-10-21 |
| FIT CHECKER II (K032289) | GC America, Inc. | 2003-10-20 |
| MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME (K032978) | Ciba Vision Corporation | 2003-10-20 |
| ITI SYNOCTA MESO ABUTMENTS (K033243) | Straumann USA | 2003-10-20 |
| GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM (K032819) | Bionostics, Inc. | 2003-10-20 |
| HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM (K033248) | Hitachi Medical Systems America, Inc. | 2003-10-20 |
| EPT CERTAINTY PREGNANCY TEST (K032939) | Unipath , Ltd. | 2003-10-20 |
| 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES (K033121) | Synthes (Usa) | 2003-10-20 |
| VIVASENS (K030922) | Ivoclar Vivadent, Inc. | 2003-10-17 |
| ROCHE DIAGNOSTICS OMNI S ANALYZER (K032311) | Roche Diagnostics Corp. | 2003-10-17 |
| NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 (K032947) | Dolphin Medical, Inc. | 2003-10-17 |
| AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST (K031497) | Amedica Biotech, Inc. | 2003-10-17 |
| EZ SPLINT & EZ SPLINT PM (K022809) | Power Products, Inc.-Splintek | 2003-10-17 |
| SHANGHAI GIANTMAX CLEAR VINYL POWDER FREE EXAMINATION GLOVES (K032746) | Shanghai Giantmax Plastic Product Corp. | 2003-10-17 |
| VIEWMATE ULTRASOUND IMAGING SYSTEM (K031066) | Ep Medsystems | 2003-10-17 |
| MODEL 3100 WRISTOX PULSE OXIMETER (K030668) | Nonin Medical, Inc. | 2003-10-17 |
| MICROGENICS CYCLOSPORINE CONTROL KIT (K032842) | Microgenics Corp. | 2003-10-17 |
| PROPHY-MATE (K032395) | Nakanishi, Inc. | 2003-10-17 |
| SHANGHAI GIANTMAX POWDERED CLEAR VINYL EXAMINATION GLOVES (K032745) | Shanghai Giantmax Plastic Product Corp. | 2003-10-17 |
| MAXTER STERILE POWDER FREE SURGICAL GLOVES (K032501) | Maxter Glove Manufacturing Sdn Bhd | 2003-10-17 |
| RADIUS COUGAR WIRE (K032899) | Radius Medical Technologies, Inc. | 2003-10-17 |
| MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR (K032801) | Albert Browne , Ltd. | 2003-10-17 |
| POWDER FREE LATEX EXAM GLOVES (K031335) | Tan Sin Lian Industries Sdn. Bhd. | 2003-10-16 |
| ENK FIBEROPTIC ATOMIZER SET (K031966) | Cook, Inc. | 2003-10-16 |
| UUHC REPROCESSED COMPRESSION SLEEVE DEVICES (K031189) | University of Utah Hospitals and Clinics | 2003-10-16 |
| VISTAKON (GALYFILCON A) SOFT CONTACT LENS (K032340) | Johnson & Johnson Vision Care, Inc. | 2003-10-16 |
| STRYKER FLEXIBLE URETEROSCOPE (K031278) | Stryker Endoscopy | 2003-10-16 |
| MAGNETOM AVANTO MR SYSTEM (K032428) | Siemens Medical Solutions USA, Inc. | 2003-10-16 |
| MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES (K030857) | Mahe Intl., Inc. | 2003-10-16 |
| INTELEPACS (K032533) | Intelerad Medical Systems, Inc. | 2003-10-16 |
| SONOLINE ANTARES WITH CLARIFY VE (K033196) | Siemens Medical Solutions USA, Inc. | 2003-10-16 |
| AUTOSET SPIRIT SYSTEM (K032480) | Resmed, Ltd. | 2003-10-16 |
| LTV-1000 VENTILATOR (K032226) | Pulmonetic Systems, Inc. | 2003-10-16 |
| MODEL IR 1200 INSULIN PUMP (K032257) | Animas Corp. | 2003-10-16 |
| DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION (K033244) | Ge Medical Systems, Inc. | 2003-10-16 |
| EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT (K033225) | Olympus Optical Co., Ltd. | 2003-10-16 |
| HOLOGIC DR IMAGEPRO (K032546) | Hologic, Inc. | 2003-10-16 |
| ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK (K031012) | 3M Company | 2003-10-16 |
| PROWESS (K032456) | Prowess, Inc. | 2003-10-16 |
| EASYGLUCO, MODEL IGM0002 (K031501) | American Healthcare, Inc. | 2003-10-16 |
| ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 (K033009) | Roche Diagnostics Corp. | 2003-10-16 |
| ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109 (K033099) | Applied Diabetes Research, Incorporated | 2003-10-16 |
| SC TOTAL HIP SYSTEM (K031474) | Orthopedic Alliance, LLC | 2003-10-15 |
| ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING (K031301) | Cardinalhealth | 2003-10-15 |
| MEDELA CLARIO HOME CARE PUMP (K033179) | Medela AG | 2003-10-15 |
| C.T.M. MOBILITY SCOOTER, MODEL HS-250 (K032919) | C.T.M. Homecare Product, Inc. | 2003-10-15 |
| RHYTHM TOUCH Q 2-WAY (K032178) | Shockim Enterprises, Ltd. | 2003-10-15 |
| BIO-INTRAFIX TIBIAL SCREW AND SHEATH (K032167) | Mitek Worldwide | 2003-10-15 |
| DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) (K031408) | Deroyal | 2003-10-15 |
| ACURA ELITE GRAVITY COMPENSATING RESERVOIR (K030468) | Phoenix Biomedical Corp. | 2003-10-15 |
| MODIFICATION TO: HORIZON 9000WS (K032997) | Mennen Medical , Ltd. | 2003-10-15 |
| EBI ACUMEN SURGICAL NAVIGATION SYSTEM (K031732) | Ebi, L.P. | 2003-10-15 |
| COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH (K032223) | Cook Vascular, Inc. | 2003-10-15 |
| DAMON FT (K032408) | Sybron Dental Specialties, Inc. | 2003-10-15 |
| DIGITAL AMBULATORY ECG (HOLTER) RECORDER (K031074) | Datrix | 2003-10-15 |
| GENESIS II POROUS PLUS HA KNEE SYSTEM (K032683) | Smith & Nephew, Inc. | 2003-10-15 |
| BREAS PV 10I CPAP SYSTEM, MODEL PV 10I (K030985) | Vital Signs, Inc. | 2003-10-15 |
| PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW (K032792) | Shanghai Jiawang Industrial Co. , Ltd. | 2003-10-15 |
| EKG SPEAKS (K032926) | Medtronic Vascular | 2003-10-15 |
| COBAS INTEGRA ALP IFCC GEN.2 (K033185) | Roche Diagnostics Corp. | 2003-10-14 |
| PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS (K033165) | Roche Diagnostics Corp. | 2003-10-14 |
| ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE) (K032661) | ACON Laboratories, Inc. | 2003-10-14 |
| ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 (K032904) | Dentsply Intl. | 2003-10-14 |
| E-STRIP (K031769) | Eemso, Inc. | 2003-10-14 |
| REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 (K032868) | Corgenix, Inc. | 2003-10-14 |
| EKOS PERIPHERAL INFUSION SYSTEM (K033214) | Ekos Corp. | 2003-10-14 |
| AUTOALIGN (K032186) | Cortechs Labs, Inc. | 2003-10-14 |
| RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3 (K032924) | Volume Interactions Pte, Ltd. | 2003-10-10 |
| ONLINE TDM AMIKA (K032279) | Roche Diagnostics Corp. | 2003-10-10 |
| CLUED UP MULTIPURPOSE SOLUTION- NO RUB (K030910) | Clued UP Limited | 2003-10-10 |
| LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS (K033162) | Cliniqa Corporation | 2003-10-10 |
| HL888BM (K032837) | Health & Life Co., Ltd. | 2003-10-10 |
| PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT (K031901) | Stelkast Company | 2003-10-10 |
| ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01 (K031471) | Ortho Tec, LLC | 2003-10-10 |
| ACCUSONIC A-SCAN MODEL, 24-4000 (K032956) | Accutome, Inc. | 2003-10-10 |
| MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300 (K030998) | Healthonics, Inc. | 2003-10-10 |
| THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O. (K032858) | Philips Medizin Systeme Boblingen GmbH | 2003-10-10 |