| IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (K032881) | Diagnostic Products Corp. | 2003-10-10 |
| FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR (K032290) | Fukuda Denshi USA, Inc. | 2003-10-10 |
| ORTHOPHOS XG DS/CEPH (K033073) | Sirona Dental Systems GmbH | 2003-10-10 |
| TYTRON C-500IR CLINICAL INFRARED IMAGING SYSTEM (K032471) | Titronics Research & Development Co. | 2003-10-10 |
| CAREMATIX WELLNESS SYSTEM (K031840) | Carematix, Inc. | 2003-10-10 |
| NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03 (K032115) | Polyganics B.V., | 2003-10-10 |
| METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT) (K031797) | Lin-Zhi International, Inc. | 2003-10-10 |
| OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 (K030737) | Ctf Systems (2001), Inc. | 2003-10-10 |
| KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL (K033151) | Mri Devices Corp. | 2003-10-10 |
| LASERSMILE (K030539) | Biolase Technology, Inc. | 2003-10-10 |
| CARESTATION 126S VIDEOPHONE (K031863) | Motion Media Technology, Inc. | 2003-10-10 |
| INSIGHT MILLENNIUM III (K023209) | Fasstech | 2003-10-10 |
| GE 0.2T SIGNA PROFILE/I MR SYSTEM (K033168) | General Electric Co. | 2003-10-10 |
| MAXTER STERILE POWDERED LATEX SURGICAL GLOVES (K032467) | Maxter Glove Manufacturing Sdn Bhd | 2003-10-10 |
| ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL (K031607) | Orion Diagnostica, Div. Orion Corp. | 2003-10-10 |
| MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM (K032577) | Ge Medical Systems Information Technologies | 2003-10-10 |
| RUBBERCARE POWDERED LATEX EXAMINATION GLOVES (K032201) | Perusahaan Pelindung Getah (M) Sdn Bhd | 2003-10-10 |
| HL888BA (K032839) | Health & Life Co., Ltd. | 2003-10-10 |
| VIEWPOINT TELEMETRY SYSTEM (K031760) | Datascope Corp. | 2003-10-10 |
| MODIFICATION TO HL168 (K033043) | Health & Life Co., Ltd. | 2003-10-10 |
| HAC-12 AND HAC-30 HEAD ARRAY COIL (K033152) | Mri Devices Corp. | 2003-10-10 |
| POWDER FREE VINYL EXAMINATION GLOVE (K032071) | Shanghai Foremost Plastic Industrial Co., Ltd. | 2003-10-10 |
| MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATS (K032310) | Kinetic Concepts, Inc. | 2003-10-10 |
| CUF-COVER (TM) (K031195) | Ethox Corp. | 2003-10-10 |
| MODEL 2100 PULSE OXIMETER (K031465) | Dolphin Medical, Inc. | 2003-10-10 |
| GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM (K032620) | General Electric Co. | 2003-10-10 |
| KLS-MARTIN STERNAL PLATING SYSTEM (K032413) | KLS-Martin L.P. | 2003-10-10 |
| BRM2 BRAIN MONITOR (K033010) | Brainz Instruments , Ltd. | 2003-10-10 |
| DESENS-IONOMER (K032175) | Milton Hodosh, M.D. | 2003-10-09 |
| CYNOSURE SMART FILE ND:YAG LASERS (K031125) | Cynosure, Inc. | 2003-10-09 |
| SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM (K032506) | Sanarus Medical, Inc. | 2003-10-09 |
| UNOMEDICAL MONICA INFUSION SET (K032854) | Unomedical A/S | 2003-10-09 |
| PORT CASSETTE (K032654) | Orex Computed Radiography, Ltd. | 2003-10-09 |
| SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES (K033160) | Synthes (Usa) | 2003-10-09 |
| EM PROBE, EM PAD (K024361) | Em Probe, Inc. | 2003-10-09 |
| NBD DISPOSABLE RF CANNULAE (K032196) | New Business Development, LLC | 2003-10-09 |
| SHIRAZ-JAVA SPINAL FIXATION SYSTEM (K031265) | Spine Next SA | 2003-10-09 |
| FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM (K032427) | Meridan Medical | 2003-10-09 |
| GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT (K032581) | Howmedica Osteonics Corp. | 2003-10-09 |
| MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM (K030472) | Ethicon Endo-Surgery, Inc. | 2003-10-09 |
| PINNACLE3 RADIATION THERAPY PLANNING SYSTEM (K032724) | Adac Laboratories | 2003-10-09 |
| MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L) (K032768) | Medtronic Ave, Inc. | 2003-10-09 |
| VELOPEX AQUACUT FLUID ABRASION UNIT (K024105) | Velopex International, Inc. | 2003-10-09 |
| MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER (K032138) | Medtronic Vascular | 2003-10-09 |
| REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 (K032789) | American I.V. Products, Inc. | 2003-10-09 |
| ACCOLADE-J HIP STEM SERIES (K032300) | Howmedica Osteonics Corp. | 2003-10-09 |
| BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS (K032700) | Blackstone Medical, Inc. | 2003-10-09 |
| SONOMA ANTERIOR CERVICAL PLATE SYSTEM (K032368) | Seaspine | 2003-10-09 |
| NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS (K031061) | Zimmer, Inc. | 2003-10-09 |
| MAS PAR TDM (K032826) | Medical Analysis Systems, Inc. | 2003-10-09 |
| NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES (K032357) | Lumenis, Inc. | 2003-10-09 |
| T2 RECON NAIL SYSTEM (K032898) | Howmedica Osteonics Corp. | 2003-10-09 |
| US-100 PORTABLE ULTRASOUND THERAPY UNIT (K032793) | Ito Co., Ltd. | 2003-10-09 |
| METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING (K032605) | Meta Biomed Co., Ltd. | 2003-10-08 |
| GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM (K032795) | Ge Medical Systems, LLC | 2003-10-08 |
| ENDOTINE FOREHEAD DEVICE (K032770) | Coapt Systems, Inc. | 2003-10-08 |
| MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM (K032772) | Hill-Rom Manufacturing, Inc. | 2003-10-08 |
| WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A (K032960) | Wide Corporation | 2003-10-08 |
| CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS (K032437) | Roche Diagnostics Corp. | 2003-10-08 |
| I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET (K031873) | I-Stat Corporation | 2003-10-07 |
| NICO WITH MARS, MODEL 7300 (K030886) | Respironics Novametrix, Inc. | 2003-10-07 |
| DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT (K032195) | Dentaurum | 2003-10-07 |
| VIGORMIST COMPRESSOR NEBULIZER (K031413) | Vega Technologies, Inc. | 2003-10-07 |
| DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS (K023366) | Datex-Ohmeda, Inc. | 2003-10-07 |
| BETEC RETRACTABLE SAFETY SYRINGE (5ML) (K031909) | Betec Medical Science Co., Ltd. | 2003-10-07 |
| CSS (K031564) | Medical Scientific, Inc. | 2003-10-07 |
| BROTHERS POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW (K032323) | Long First (Xiamen) Plastics Co., Ltd. | 2003-10-07 |
| METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING (K032603) | Meta Biomed Co., Ltd. | 2003-10-07 |
| NUVASIVE CEMENT RESTRICTOR (K032180) | Nuvasive, Inc. | 2003-10-07 |
| JS VASCULAR GUIDE WIRE VISE/TORQUE DEVICE (K032411) | Js Vascular, Inc. | 2003-10-07 |
| 3M LIQUID BANDAGE, MODEL 120-LB (K031263) | 3M Company | 2003-10-07 |
| ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B (K032098) | Arthrex, Inc. | 2003-10-07 |
| MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS (K033039) | Mckinley, Inc. | 2003-10-07 |
| F-10 FOLDING POWER CHAIR (K032441) | Wheelchair & Scooter Express | 2003-10-06 |
| COACH 777-4 (K030757) | Wheelchair & Scooter Express | 2003-10-06 |
| DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM (K024072) | Duckworth & Kent, Ltd. | 2003-10-06 |
| CSF400 AND CSF600 (K030081) | Inmed Ltda. | 2003-10-06 |
| COACH 777-3 (K030756) | Wheelchair & Scooter Express | 2003-10-06 |
| DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES (K032668) | Kingswell International, Inc. | 2003-10-06 |
| NORMED COMPRESSION BONE SCREW SYSTEM (K032634) | Noviace Corporation | 2003-10-06 |
| C.T.M. MOBILITY SCOOTER, MODEL HS-235 (K032918) | C.T.M. Homecare Product, Inc. | 2003-10-06 |
| ACE NANCY NAIL (K032687) | DePuy Orthopaedics, Inc. | 2003-10-06 |
| LALAN GLOVES (PVT) LTD GLOVE, PATIENT EXAMINATION, LATEX (K031386) | Lalan Gloves (Pvt) , Ltd. | 2003-10-06 |
| MODIFICATION TO RENEW LEAD EXTENSION (K032751) | Advanced Neuromodulation Systems | 2003-10-06 |
| OPTIBAND LC (K032407) | Sybron Dental Specialties, Inc. | 2003-10-06 |
| DIMENSION DRUG CALIBRATOR II, MODEL DC49C (K032574) | Dade Behring, Inc. | 2003-10-06 |
| EXTERNAL DRAINAGE SET (K032817) | Integra Neurosciences Implants S.A. | 2003-10-06 |
| MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) (K032721) | Stellartech Research Corp. | 2003-10-06 |
| ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT (K032458) | Abbott Laboratories | 2003-10-06 |
| BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML (K032655) | Becton, Dickinson & CO | 2003-10-06 |
| HEART 2006 (K032736) | Aerotel Medical Systems (1998) , Ltd. | 2003-10-03 |
| EPSILON DURASUL CONSTRAINED ACETABULAR LINER (K030923) | Centerpulse Orthopedics, Inc. | 2003-10-03 |
| DISPOSABLE POWDER FREE VINYL EXAM GLOVES (K032630) | Kingswell International, Inc. | 2003-10-03 |
| VACURECT VACUUM CONSTRICTION DEVICE (K032776) | Vacurect Manufacturing (Pty) , Ltd. | 2003-10-03 |
| VIVATIP MICROWAVE ABLATION PROBE (K032702) | Vivant Medical, Inc. | 2003-10-03 |
| PLACER (K032349) | Advanced Neuromodulation Systems | 2003-10-03 |
| MOSFET AUTOSENSE WIRELESS (K032725) | Thomson & Nielsen Electronics, Ltd. | 2003-10-03 |
| ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221 (K032461) | Lin-Zhi International, Inc. | 2003-10-03 |
| MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASER (K032231) | Medx Electronics, Inc. | 2003-10-03 |
| MEDS-4-INF+ (K032055) | Medical Equipment Device Specialists | 2003-10-03 |